<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03781804</url>
  </required_header>
  <id_info>
    <org_study_id>OPN-FLU-CS-3205</org_study_id>
    <nct_id>NCT03781804</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps</brief_title>
  <official_title>A 24-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optinose US Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Optinose US Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter&#xD;
      study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg&#xD;
      twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without&#xD;
      nasal polyps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to compare the efficacy of intranasal administration&#xD;
      of twice-daily doses of 186 and 372 µg of OPN-375 (fluticasone propionate) with placebo in&#xD;
      subjects with chronic rhinosinusitis using the following co-primary endpoints:&#xD;
&#xD;
        1. A change from baseline in symptoms as measured by a composite score of nasal congestion,&#xD;
           facial pain or pressure sensation, and nasal discharge (anterior and/or posterior) at&#xD;
           the end of Week 4.&#xD;
&#xD;
        2. A change from baseline to Week 24/Early Termination (ET) in the average percent of the&#xD;
           volume opacified in the ethmoid and maxillary sinuses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">January 19, 2022</completion_date>
  <primary_completion_date type="Actual">January 19, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains</measure>
    <time_frame>Week 24</time_frame>
    <description>The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem,3=moderate problem, 4=severe problem, 5=problem as bad as it can be.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior)</measure>
    <time_frame>Week 12</time_frame>
    <description>Change from baseline in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours), The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours) The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. The change reported in the results is calculated by subtracting the score reported at Baseline from the score reported at Visit 4 (Week 12).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.&#xD;
The value reported in the results is calculated by subtracting the score reported by the patient at Baseline from the score reported by the patient at Visit 4 (Week 12).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for CRS with Nasal Polyps (NP) and without NP sub-groups and in patients with and without previous sinus surgery. Percent volume opacified can range from 0% to 100%. Outcome measure is percentage change from percent opacification at baseline to percent opacification at Week 24; therefor, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for each of the left and right ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).&#xD;
The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 [Wk 24] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs</measure>
    <time_frame>Week 24</time_frame>
    <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).&#xD;
Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment</measure>
    <time_frame>Baseline, Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Comparison to First Acute Exacerbation of Chronic Sinusitis</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Requiring Rescue Medication After Week 4</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Recording of each dose of approved rescue medication after the Week 4 visit through Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>12 Weeks, 24 Weeks</time_frame>
    <description>The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 &quot;component&quot; scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Week 4, Week 24</time_frame>
    <description>Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)</measure>
    <time_frame>Week 24</time_frame>
    <description>The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Change from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the SF-36v2 Physical Composite Score (PCS)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Change from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Percentage of subjects indicating that they are willing to consider Sinus Surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Percentage of Subjects who meet the minimal objective criteria for surgical intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery</measure>
    <time_frame>Week 24</time_frame>
    <description>Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).</measure>
    <time_frame>24 Weeks</time_frame>
    <description>The Health and Work Performance Questionnaire measures work productivity (absenteeism and presenteeism). - Absenteeism is measured in missed work days over the past four weeks (range 0-20); absenteeism is measured in % productivity at work (0-100%), with higher values indicating improved productivity. - Presenteeism can be converted to number of days of productive time lost per month, and when added to the number of lost days due to absenteeism provides an estimate of total productive work days lost.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of Safety by Recording the Severity of Adverse Events (AEs)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of Safety-Nasal Examination</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum.</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of Safety Measuring Vital Signs- Blood Pressure</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of Safety Measuring Vital Signs- Pulse</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Measure pulse in beats per minute (bpm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of Safety Measuring Vital Signs- Weight</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Assessment of safety from physical examination-weight measured in kg or lb</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of Safety - Monitoring Concomitant Medication Usage</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Assessment for safety from the collection of information for concomitant medications usage</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">332</enrollment>
  <condition>Chronic Rhinosinusitis</condition>
  <arm_group>
    <arm_group_label>OPN-375 186 μg BID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>OPN-375 186 μg BID x 24 Weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPN-375 372 μg BID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>OPN-375 372 μg BID x 24 Weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching Placebo BID x 24 Weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OPN-375</intervention_name>
    <description>OPN-375, BID</description>
    <arm_group_label>OPN-375 186 μg BID</arm_group_label>
    <arm_group_label>OPN-375 372 μg BID</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Potential subjects must meet the following criteria to enter this study:&#xD;
&#xD;
          1. men or women aged 18 years and older at baseline visit&#xD;
&#xD;
          2. women of childbearing potential must be abstinent, or if sexually active,&#xD;
&#xD;
               1. be practicing an effective method of birth control (eg, prescription oral&#xD;
                  contraceptives, contraceptive injections, contraceptive patch, intrauterine&#xD;
                  device, double-barrier method [eg, condoms, diaphragm, or cervical cap with&#xD;
                  spermicidal foam, cream, or gel], or male partner sterilization) before entry and&#xD;
                  throughout the study, or&#xD;
&#xD;
               2. be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal&#xD;
                  ligation, or otherwise be incapable of pregnancy), or&#xD;
&#xD;
               3. be postmenopausal (amenorrhea for at least 1 year)&#xD;
&#xD;
          3. women of child-bearing potential must have a negative urine pregnancy test at Visit 1&#xD;
             (Screening)&#xD;
&#xD;
          4. must have a history of chronic rhinosinusitis (CRS) and be currently experiencing 2 or&#xD;
             more of the following symptoms, 1 of which has to be either nasal congestion or nasal&#xD;
             discharge (anterior and/or posterior nasal discharge) for equal to or greater than 12&#xD;
             weeks:&#xD;
&#xD;
               -  nasal congestion&#xD;
&#xD;
               -  nasal discharge (anterior and/or posterior nasal discharge)&#xD;
&#xD;
               -  facial pain or pressure&#xD;
&#xD;
               -  reduction or loss of smell&#xD;
&#xD;
          5. endoscopic evidence of nasal mucosal disease, with edema, purulent discharge, or&#xD;
             polyps in middle meatus, bilaterally, or presence of bilateral disease on a prior&#xD;
             computed tomography (CT) scan performed within 14 days of Visit 1&#xD;
&#xD;
          6. must have confirmatory evidence via a CT scan of bilateral sinus disease (have at&#xD;
             least 1 sinus on each side of nose with a Lund-Mackay score of ≥1)&#xD;
&#xD;
          7. baseline CT scan must show a combined ≥25% opacification of the ethmoid sinuses and&#xD;
             ≥25% opacification of at least 1 maxillary sinus&#xD;
&#xD;
          8. must have at least moderate symptoms (as defined in protocol) of nasal congestion as&#xD;
             reported by the subject, on average, for the 7-day period preceding Visit 1&#xD;
             (Screening) run-in&#xD;
&#xD;
          9. must have an average morning score of at least 1.5 for congestion on the Nasal Symptom&#xD;
             Scale (as defined in protocol) recorded on the subject diary over a 7-day period&#xD;
             during the first 14 days of the single-blind run-in period&#xD;
&#xD;
         10. must demonstrate an ability to correctly complete the daily diary during the run-in&#xD;
             period to be eligible for randomization&#xD;
&#xD;
         11. Subjects with comorbid asthma or chronic obstructive pulmonary disorder (COPD) must be&#xD;
             stable with no exacerbations (eg, no emergency room visits, hospitalizations, or oral&#xD;
             or parenteral steroid use) within the 3 months before Visit 1 (Screening). Inhaled&#xD;
             corticosteroid use must be limited to stable doses of no more than 1,000 μg/day of&#xD;
             beclomethasone (or equivalent) for at least 3 months before Visit 1 (Screening) with&#xD;
             plans to continue use throughout the study.&#xD;
&#xD;
         12. Subjects with aspirin-exacerbated respiratory disease, who have undergone aspirin&#xD;
             desensitization and are receiving daily aspirin therapy, must be receiving therapy for&#xD;
             at least 6 months prior to Visit 1.&#xD;
&#xD;
         13. must be able to cease treatment with intranasal steroids, inhaled corticosteroids&#xD;
             (except permitted doses listed above for asthma and COPD) at the screening visit&#xD;
&#xD;
         14. must be able to cease treatment with oral and nasal decongestants and antihistamines&#xD;
             at Visit 1 (Screening)&#xD;
&#xD;
         15. must be able to use the exhalation delivery system (EDS) correctly; all subjects will&#xD;
             be required to demonstrate correct use with the practice EDS at Visit 1 (Screening).&#xD;
&#xD;
         16. must be capable, in the opinion of the investigator, of providing informed consent to&#xD;
             participate in the study. Subjects must sign an informed consent document indicating&#xD;
             that they understand the purpose of and procedures required for the study and are&#xD;
             willing to participate in the study.&#xD;
&#xD;
        Potential subjects who meet any of the following criteria will be excluded from entering&#xD;
        this study:&#xD;
&#xD;
          1. women who are pregnant or lactating&#xD;
&#xD;
          2. inability to have each nasal cavity examined for any reason, including nasal septum&#xD;
             deviation&#xD;
&#xD;
          3. inability to achieve bilateral nasal airflow&#xD;
&#xD;
          4. is currently taking XHANCE®&#xD;
&#xD;
          5. have previously used XHANCE for more than 1 month and did not achieve an adequate&#xD;
             symptomatic response&#xD;
&#xD;
          6. the nasal/sinus anatomy prevents the accurate assessment of sinus volume via CT scan&#xD;
&#xD;
          7. history of sinus or nasal surgery within 6 months before Visit 1 or has not healed&#xD;
             from a prior sinus or nasal surgery&#xD;
&#xD;
          8. have current evidence of odontogenic sinusitis, sinus mucocele (the affected sinus is&#xD;
             completely opacified and either the margins are expanded and/or thinned OR there are&#xD;
             areas of complete bone resorption resulting in bony defect and extension of the &quot;mass&quot;&#xD;
             into adjacent tissues), evidence of allergic fungal sinusitis, or evidence of&#xD;
             complicated sinus disease (including, but not limited to, extension of inflammation&#xD;
             outside of the sinuses and nasal cavity)&#xD;
&#xD;
          9. have a paranasal sinus or nasal tumor&#xD;
&#xD;
         10. have a polyp extending outside the ostiomeatal complex/middle turbinate (anterior or&#xD;
             inferior) that is below the inferior turbinate attachment as determined by the&#xD;
             nasoendoscopy at screening&#xD;
&#xD;
         11. have a nasal septum perforation&#xD;
&#xD;
         12. have had more than 1 episode of epistaxis with frank bleeding in the month before&#xD;
             Visit 1 (Screening)&#xD;
&#xD;
         13. have evidence of significant mucosal injury, ulceration (eg, exposed cartilage) on&#xD;
             Visit 1 (Screening) nasal examination/nasoendoscopy&#xD;
&#xD;
         14. have current, ongoing rhinitis medicamentosa (rebound rhinitis)&#xD;
&#xD;
         15. have significant oral structural abnormalities (eg, a cleft palate)&#xD;
&#xD;
         16. have a diagnosis of cystic fibrosis&#xD;
&#xD;
         17. history of eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or&#xD;
             dyskinetic ciliary syndromes&#xD;
&#xD;
         18. Symptom resolution or last dose of antibiotics for purulent nasal infection, acute&#xD;
             sinusitis, or upper respiratory tract infection, influenza, or SARS-CoV-2 (COVID-19)&#xD;
             has not occurred before Visit 1 or was less than 4 weeks before the CT scan. Potential&#xD;
             subjects presenting with any of these infections may be rescreened 4 weeks after&#xD;
             symptom resolution.&#xD;
&#xD;
         19. planned sinonasal surgery during the period of the study&#xD;
&#xD;
         20. allergy, hypersensitivity, or contraindication to corticosteroids or steroids&#xD;
&#xD;
         21. has used oral steroids in the past for treatment of CRS and did not experience any&#xD;
             relief of symptoms&#xD;
&#xD;
         22. has a steroid eluting sinus stent still in place within 30 days of Visit 1&#xD;
&#xD;
         23. allergy or hypersensitivity to any excipients in study drug&#xD;
&#xD;
         24. exposure to any glucocorticoid treatment with potential for systemic effects (eg,&#xD;
             oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids)&#xD;
             within 1 month before Visit 1 (Screening); except as noted in inclusion criteria for&#xD;
             subjects with comorbid asthma or COPD&#xD;
&#xD;
         25. have nasal candidiasis&#xD;
&#xD;
         26. history or current diagnosis of any form of glaucoma or ocular hypertension&#xD;
&#xD;
         27. history of intraocular pressure (IOP) elevation on any form of steroid therapy&#xD;
&#xD;
         28. history or current diagnosis of the presence (in either eye) of a cataract unless both&#xD;
             natural intraocular lenses have been removed&#xD;
&#xD;
         29. history of immunodeficiency&#xD;
&#xD;
         30. any serious or unstable concurrent disease, psychiatric disorder, or any significant&#xD;
             condition that, in the opinion of the investigator could confound the results of the&#xD;
             study or could interfere with the subject's participation or compliance in the study&#xD;
&#xD;
         31. have a positive drug screen or a recent (within 1 year of Visit 1 [Screening]) history&#xD;
             of drug or alcohol abuse, or dependence that, in the opinion of the investigator could&#xD;
             interfere with the subject's participation or compliance in the study&#xD;
&#xD;
         32. have participated in an investigational drug clinical trial within 30 days of Visit 1&#xD;
             (Screening)&#xD;
&#xD;
         33. have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®),&#xD;
             omalizumab (Xolair®), or benralizumab (Fasenra™) within 6 months of Visit 1&#xD;
             (Screening)&#xD;
&#xD;
         34. is using strong cytochrome P450 3A4 (CYP3A4) inhibitor (eg, ritonavir, atazanavir,&#xD;
             clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir,&#xD;
             ketoconazole, telithromycin, conivaptan, lopinavir, voriconazole, cobicistat)&#xD;
&#xD;
         35. is an employee of the investigator or study center, with direct involvement in the&#xD;
             proposed study or other studies under the direction of that investigator or study&#xD;
             center, or is a family member of the employee or the investigator&#xD;
&#xD;
         36. Patients who report unexplained worsening of vision within the past 3 months (e.g.&#xD;
             difficulty reading or seeing traffic signs from a distance.). A diagnosis of&#xD;
             presbyopia established by an eye doctor is not exclusionary&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Carothers</last_name>
    <role>Study Director</role>
    <affiliation>Optinose US Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Messina</last_name>
    <role>Study Chair</role>
    <affiliation>Optinose US Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Allergy &amp; Immunology Research</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kern Research</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento Ear, Nose &amp; Throat Surgical and Medical Group Inc</name>
      <address>
        <city>Folsom</city>
        <state>California</state>
        <zip>95630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Specialists Medical Group</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jonathan Corren, MD, Clinical Research Division</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento Ear, Nose &amp; Throat</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Associates of Santa Clara Valley</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Breathe Clear Institute</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado ENT &amp; Allergy</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine Section of Otolaryngology</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University MOT</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Allergy Sinus Asthma</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced ENT and Allergy</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Head &amp; Neck</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50312-3505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentuckiana Ear Nose &amp; Throat</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ear, Nose and Throat Associates at Greater Baltimore Medical Center</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Cloud Ear, Nose &amp; Throat</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri, Dept of Otorlaryngology</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma, Allergy, and Immunology Associates, PC</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Research Center</name>
      <address>
        <city>Ocean City</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT and Allergy Associates</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Downtown Union Square</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madison ENT and Facial Plastic Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma &amp; Immunology Relief of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma &amp; Clinical Research Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vital Prospects Clinical Research Institute, P.C.</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Research Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialty Physician Associates</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital at the University of PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Allergy and Asthma Research</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of TX Health Science Ctr at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>STAAMP Research, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chrysallis Clinical Research</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Ear, Nose &amp; Throat</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellingham Asthma, Allergy &amp; Immunology Clinic</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spokane ENT</name>
      <address>
        <city>Spokane Valley</city>
        <state>Washington</state>
        <zip>99201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT - Kaspela EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MC Iskar</name>
      <address>
        <city>Sofia</city>
        <zip>1000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Serdika</name>
      <address>
        <city>Sofia</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MC Pirogov</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Military Medical Academy (MHAT)</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Мinistry of Interior - Medical Institute</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia and Providence Health Care</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare London</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec, pavillon Hopital Saint- Sacrement</name>
      <address>
        <city>Québec</city>
        <zip>G1S 4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ltd Acad. Fridon Todua Medical Center</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ltd Israel-Georgian Medical Research Clinic - Helsicore</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JSC Curatio</name>
      <address>
        <city>Tbilisi</city>
        <zip>0114</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ltd Aversi Clinic</name>
      <address>
        <city>Tbilisi</city>
        <zip>0160</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ltd Simon Khechinashvili University Hospital</name>
      <address>
        <city>Tbilisi</city>
        <zip>0179</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicus Sp z o.o.</name>
      <address>
        <city>Wrocław</city>
        <state>Dolnoslaskie</state>
        <zip>50-224</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Biotamed</name>
      <address>
        <city>Wieliczka</city>
        <state>Malopolskie</state>
        <zip>32-020</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jarosław Ślifirski Indywidualna Praktyka Lekarska</name>
      <address>
        <city>Kęty</city>
        <state>MA</state>
        <zip>32-650</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mini Clinic Paweł Białogłowski</name>
      <address>
        <city>Łańcut</city>
        <state>PK</state>
        <zip>37-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Angelius Provita</name>
      <address>
        <city>Katowice</city>
        <state>SL</state>
        <zip>40-611</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Centrum Medyczne LiMED</name>
      <address>
        <city>Tarnowskie Góry</city>
        <state>SL</state>
        <zip>42-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Imedica</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolska</state>
        <zip>60-537</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ReumaClinic</name>
      <address>
        <city>Białystok</city>
        <zip>15-181</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Przychodnia &quot;Narutowicza&quot;</name>
      <address>
        <city>Inowrocław</city>
        <zip>88-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne All Med - Krakow</name>
      <address>
        <city>Kraków</city>
        <zip>30-033</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Woś i Piwowarczyk</name>
      <address>
        <city>Kraków</city>
        <zip>31-572</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Alergologii</name>
      <address>
        <city>Lublin</city>
        <zip>20-552</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie</name>
      <address>
        <city>Strzelce Opolskie</city>
        <zip>47-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ &quot;Ignis&quot; dr med. Alicja Łobińska</name>
      <address>
        <city>Świdnik</city>
        <zip>21-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Przychodnia Medycyny Rodzinnej</name>
      <address>
        <city>Świętochłowice</city>
        <zip>41-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I.M. Sechenov First Moscow State Medical University-University Hospital No.1 - Ear, Nose, and Throat Clinic</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaya Obl.</state>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow Regional Scientific Research Clinical Institute n.a. M.F. Vladimirsky (MONIKI)</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaya Obl.</state>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg State Medical University n.a. I.P. Pavlov</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Saint-Petersburg</state>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smolensk, &quot;Uromed&quot;</name>
      <address>
        <city>Smolensk</city>
        <state>Smolenskaya Obl</state>
        <zip>214031</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional Clinical Hospital</name>
      <address>
        <city>Yaroslavl</city>
        <state>Yaroslavskaya Obl.</state>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Clinical Hospital with Polyclinic&quot; Office of Affairs of the President of the Russian Federation</name>
      <address>
        <city>Moscow</city>
        <zip>121359</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg Institute of Ear, Nose, Throat, and Speech (The RSFSR Ministry of Health)</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>190013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ONH Klinikun Skane Universitetssjukhuset (Lund - Oron- Nas- Och Halskliniken)</name>
      <address>
        <city>Lund</city>
        <state>Skane Lan</state>
        <zip>222 41</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholms Lan</state>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsingborg Hospital</name>
      <address>
        <city>Helsingborg</city>
        <state>Sverige</state>
        <zip>25187</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ONH Kliniken Sahlgrenska Universitetsynkhiset</name>
      <address>
        <city>Gothenburg</city>
        <state>Vastra Gotaland Lan</state>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sofiahemmet Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>114 28</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <state>Cf14 4xw</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Darlington Memorial Hospital</name>
      <address>
        <city>Darlington</city>
        <zip>DL3 6HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lister Hospital</name>
      <address>
        <city>Stevenage</city>
        <zip>SG1 4AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stockport NHS Foundation Trust (Stepping Hill Hospital Base)</name>
      <address>
        <city>Stockport</city>
        <zip>SK2 7JE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wrightington, Wigan and Leigh NHS Foundation Trust</name>
      <address>
        <city>Wigan</city>
        <zip>WN1 2NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Georgia</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>June 15, 2023</results_first_submitted>
  <results_first_submitted_qc>September 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 18, 2023</results_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Nasal Polyps</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 7, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03781804/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 14, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03781804/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OPN-375 186 μg BID</title>
          <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, Twice Daily (BID)</description>
        </group>
        <group group_id="P2">
          <title>OPN-375 372 μg BID</title>
          <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, Twice Daily (BID)</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, Twice Daily (BID)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="109"/>
                <participants group_id="P3" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not provided</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OPN-375 186 μg BID</title>
          <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
        </group>
        <group group_id="B2">
          <title>OPN-375 372 μg BID</title>
          <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="111"/>
            <count group_id="B2" value="109"/>
            <count group_id="B3" value="112"/>
            <count group_id="B4" value="332"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="89"/>
                    <measurement group_id="B4" value="277"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Mean</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.4" spread="13.85"/>
                    <measurement group_id="B2" value="49.6" spread="13.49"/>
                    <measurement group_id="B3" value="49.2" spread="15.26"/>
                    <measurement group_id="B4" value="49.1" spread="14.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="104"/>
                    <measurement group_id="B4" value="314"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="299"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intranasal corticosteroid treatment for chronic sinusitis within the last 10 years</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Mometason Furoate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fluticasone proprionate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fluticasone Furoate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Budesonide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ciclesonide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beclomethasone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triamcinolone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flunisolide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fluticasone and azelastine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="104"/>
                    <measurement group_id="B4" value="304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Sinusitis Surgery</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Any surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endoscopic sinus surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Balloon sinuplasty</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polypectomy alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus stent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Propel mometasone furoate implant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinuva mometasone furoate sinus implant : Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Other Chronic Sinusitis Treatment History</title>
          <description>History of treatment for Chronic Sinusitis other than corticosteroids and surgery.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Systemic antibiotic in last 5 years</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="70"/>
                    <measurement group_id="B4" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Saline lavage</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sinus imaging in last year</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>CT scans</title>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MRI scans</title>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="105"/>
                    <measurement group_id="B4" value="318"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking History</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Current cigarette smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current smoker (other forms of tobacco)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4</title>
        <description>Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.</description>
        <time_frame>4 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4</title>
          <description>Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.58" spread="0.161"/>
                    <measurement group_id="O2" value="-1.60" spread="0.163"/>
                    <measurement group_id="O3" value="-0.62" spread="0.161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses</title>
        <description>Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses</title>
          <description>Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.</description>
          <population>Full analysis set</population>
          <units>Percentage of volume opacified</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.58" spread="1.436"/>
                    <measurement group_id="O2" value="-6.20" spread="1.412"/>
                    <measurement group_id="O3" value="-1.60" spread="1.421"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains</title>
        <description>The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem,3=moderate problem, 4=severe problem, 5=problem as bad as it can be.</description>
        <time_frame>Week 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains</title>
          <description>The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem,3=moderate problem, 4=severe problem, 5=problem as bad as it can be.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.05" spread="1.687"/>
                    <measurement group_id="O2" value="-22.77" spread="1.709"/>
                    <measurement group_id="O3" value="-10.16" spread="1.723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior)</title>
        <description>Change from baseline in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.</description>
        <time_frame>Week 12</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior)</title>
          <description>Change from baseline in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.89" spread="0.204"/>
                    <measurement group_id="O2" value="-2.18" spread="0.208"/>
                    <measurement group_id="O3" value="-1.35" spread="0.208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores</title>
        <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours), The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.</description>
        <time_frame>12 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores</title>
          <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours), The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="0.074"/>
                    <measurement group_id="O2" value="-0.84" spread="0.076"/>
                    <measurement group_id="O3" value="-0.45" spread="0.076"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.68" spread="0.075"/>
                    <measurement group_id="O2" value="-0.82" spread="0.076"/>
                    <measurement group_id="O3" value="-0.41" spread="0.076"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores</title>
        <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours) The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. The change reported in the results is calculated by subtracting the score reported at Baseline from the score reported at Visit 4 (Week 12).</description>
        <time_frame>12 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores</title>
          <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours) The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. The change reported in the results is calculated by subtracting the score reported at Baseline from the score reported at Visit 4 (Week 12).</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="107"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.60" spread="0.078"/>
                    <measurement group_id="O2" value="-0.54" spread="0.079"/>
                    <measurement group_id="O3" value="-0.31" spread="0.079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.54" spread="0.078"/>
                    <measurement group_id="O2" value="-0.56" spread="0.080"/>
                    <measurement group_id="O3" value="-0.32" spread="0.079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores</title>
        <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.</description>
        <time_frame>12 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores</title>
          <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="107"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.65" spread="0.075"/>
                    <measurement group_id="O2" value="-0.74" spread="0.076"/>
                    <measurement group_id="O3" value="-0.43" spread="0.077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="0.077"/>
                    <measurement group_id="O2" value="-0.72" spread="0.078"/>
                    <measurement group_id="O3" value="-0.37" spread="0.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores</title>
        <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.&#xD;
The value reported in the results is calculated by subtracting the score reported by the patient at Baseline from the score reported by the patient at Visit 4 (Week 12).</description>
        <time_frame>12 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores</title>
          <description>Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.&#xD;
The value reported in the results is calculated by subtracting the score reported by the patient at Baseline from the score reported by the patient at Visit 4 (Week 12).</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="107"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="0.078"/>
                    <measurement group_id="O2" value="-0.61" spread="0.079"/>
                    <measurement group_id="O3" value="-0.48" spread="0.079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PM Diary Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.52" spread="0.077"/>
                    <measurement group_id="O2" value="-0.57" spread="0.079"/>
                    <measurement group_id="O3" value="-0.43" spread="0.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations</title>
        <description>Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for CRS with Nasal Polyps (NP) and without NP sub-groups and in patients with and without previous sinus surgery. Percent volume opacified can range from 0% to 100%. Outcome measure is percentage change from percent opacification at baseline to percent opacification at Week 24; therefor, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.</description>
        <time_frame>24 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations</title>
          <description>Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for CRS with Nasal Polyps (NP) and without NP sub-groups and in patients with and without previous sinus surgery. Percent volume opacified can range from 0% to 100%. Outcome measure is percentage change from percent opacification at baseline to percent opacification at Week 24; therefor, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.</description>
          <population>Full analysis set</population>
          <units>percentage of volume opacified</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nasal Polyps Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.01" spread="1.741"/>
                    <measurement group_id="O2" value="-4.64" spread="1.744"/>
                    <measurement group_id="O3" value="1.29" spread="1.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Polyps Absent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.52" spread="2.389"/>
                    <measurement group_id="O2" value="-7.90" spread="2.287"/>
                    <measurement group_id="O3" value="-5.50" spread="2.309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Sinus Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.58" spread="2.156"/>
                    <measurement group_id="O2" value="-8.91" spread="2.235"/>
                    <measurement group_id="O3" value="-1.65" spread="2.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Prior Sinus Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.30" spread="1.913"/>
                    <measurement group_id="O2" value="-3.82" spread="1.787"/>
                    <measurement group_id="O3" value="-0.95" spread="1.810"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score</title>
        <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for each of the left and right ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score</title>
          <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for each of the left and right ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" spread="0.269"/>
                    <measurement group_id="O2" value="-0.46" spread="0.267"/>
                    <measurement group_id="O3" value="0.10" spread="0.266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined</title>
        <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).&#xD;
The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 [Wk 24] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).</description>
        <time_frame>24 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined</title>
          <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).&#xD;
The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 [Wk 24] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.148"/>
                    <measurement group_id="O2" value="0.04" spread="0.149"/>
                    <measurement group_id="O3" value="0.37" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs</title>
        <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).&#xD;
Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).</description>
        <time_frame>Week 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs</title>
          <description>Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).&#xD;
Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ethmoid Sinus Anterior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.064"/>
                    <measurement group_id="O2" value="-0.01" spread="0.063"/>
                    <measurement group_id="O3" value="0.07" spread="0.064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ethmoid Sinus Posterior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.066"/>
                    <measurement group_id="O2" value="-0.04" spread="0.067"/>
                    <measurement group_id="O3" value="0.15" spread="0.068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maxillary Sinus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.049"/>
                    <measurement group_id="O2" value="0.09" spread="0.051"/>
                    <measurement group_id="O3" value="0.12" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frontal Sinus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.072"/>
                    <measurement group_id="O2" value="0.01" spread="0.071"/>
                    <measurement group_id="O3" value="0.01" spread="0.070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sphenoid Sinus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.067"/>
                    <measurement group_id="O2" value="-0.03" spread="0.068"/>
                    <measurement group_id="O3" value="0.08" spread="0.069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ostiomeatal Complex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.129"/>
                    <measurement group_id="O2" value="-0.47" spread="0.129"/>
                    <measurement group_id="O3" value="-0.31" spread="0.129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment</title>
          <population>Full analysis set</population>
          <units>Percent opacified volume</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.70" spread="2.23"/>
                    <measurement group_id="O2" value="-12.62" spread="2.3"/>
                    <measurement group_id="O3" value="-7.61" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment</title>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment</title>
          <population>Full analysis set</population>
          <units>Percent opacified volume</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.31" spread="1.43"/>
                    <measurement group_id="O2" value="-7.43" spread="1.44"/>
                    <measurement group_id="O3" value="-3.76" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations</title>
        <description>Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.</description>
        <time_frame>24 Weeks</time_frame>
        <population>Data is provided for the total population and 4 subgroups. The population of the subgroups will not equal the total population, as they are only a portion of subjects from the total.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations</title>
          <description>Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.</description>
          <population>Data is provided for the total population and 4 subgroups. The population of the subgroups will not equal the total population, as they are only a portion of subjects from the total.</population>
          <units>Percent opacified volume</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Full Population</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.27" spread="1.81"/>
                    <measurement group_id="O2" value="-10.39" spread="1.83"/>
                    <measurement group_id="O3" value="-6.51" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRSwNP SubGroup</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.54" spread="1.77"/>
                    <measurement group_id="O2" value="-6.72" spread="1.81"/>
                    <measurement group_id="O3" value="-3.23" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRSsNP SubGroup</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.88" spread="2.37"/>
                    <measurement group_id="O2" value="-7.89" spread="2.37"/>
                    <measurement group_id="O3" value="-3.88" spread="2.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Prior Sinus Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.29" spread="2.67"/>
                    <measurement group_id="O2" value="-12.44" spread="2.89"/>
                    <measurement group_id="O3" value="-3.24" spread="2.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects without Prior Sinus Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.00" spread="2.46"/>
                    <measurement group_id="O2" value="-8.83" spread="2.30"/>
                    <measurement group_id="O3" value="-8.39" spread="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score</title>
        <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score</title>
          <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.98" spread="0.65"/>
                    <measurement group_id="O2" value="-1.95" spread="0.64"/>
                    <measurement group_id="O3" value="-0.03" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined</title>
        <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined</title>
          <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.21" spread="0.43"/>
                    <measurement group_id="O2" value="-1.44" spread="0.43"/>
                    <measurement group_id="O3" value="-0.19" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs</title>
        <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).</description>
        <time_frame>Baseline, Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs</title>
          <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anterior Ethmoid Sinus Pair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" spread="0.17"/>
                    <measurement group_id="O2" value="-0.53" spread="0.17"/>
                    <measurement group_id="O3" value="-0.19" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posterior Ethmoid Sinus Pair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.18"/>
                    <measurement group_id="O2" value="-0.55" spread="0.18"/>
                    <measurement group_id="O3" value="0.03" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maxillary Sinus Pair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="0.18"/>
                    <measurement group_id="O2" value="-0.39" spread="0.17"/>
                    <measurement group_id="O3" value="-0.08" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frontal Sinus Pair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.20"/>
                    <measurement group_id="O2" value="-0.16" spread="0.20"/>
                    <measurement group_id="O3" value="0.05" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sphenoid Sinus Pair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.20"/>
                    <measurement group_id="O2" value="-0.16" spread="0.19"/>
                    <measurement group_id="O3" value="0.20" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations</title>
        <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Data provided for full population and CRSwNP, CRSsNP, subjects with prior sinus surgery, and subjects without prior sinus surgery subgroups. Number of participants analyzed in the subgroups will be less than the total overall, as these are only portions of the total population.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations</title>
          <description>Zeinrich Modification of the Lund-Mackay Staging System:&#xD;
Zeinrich modified the LM system by creating subdivisions within &quot;partial opacification&quot; and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%</description>
          <population>Data provided for full population and CRSwNP, CRSsNP, subjects with prior sinus surgery, and subjects without prior sinus surgery subgroups. Number of participants analyzed in the subgroups will be less than the total overall, as these are only portions of the total population.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Population</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.59" spread="0.11"/>
                    <measurement group_id="O2" value="-0.60" spread="0.11"/>
                    <measurement group_id="O3" value="-0.45" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRSwNP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.49" spread="0.13"/>
                    <measurement group_id="O2" value="-0.57" spread="0.14"/>
                    <measurement group_id="O3" value="-0.30" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRSsNP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="0.18"/>
                    <measurement group_id="O2" value="-0.61" spread="0.18"/>
                    <measurement group_id="O3" value="-0.64" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Prior Sinus Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.48" spread="0.16"/>
                    <measurement group_id="O2" value="-0.78" spread="0.17"/>
                    <measurement group_id="O3" value="-0.33" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects without Prior Sinus Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="0.15"/>
                    <measurement group_id="O2" value="-0.51" spread="0.14"/>
                    <measurement group_id="O3" value="-0.54" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Comparison to First Acute Exacerbation of Chronic Sinusitis</title>
        <description>Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment</description>
        <time_frame>24 Weeks</time_frame>
        <population>Number of patients experiencing exacerbation within each treatment group.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Time Comparison to First Acute Exacerbation of Chronic Sinusitis</title>
          <description>Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment</description>
          <population>Number of patients experiencing exacerbation within each treatment group.</population>
          <units>Weeks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.44" spread="0.55"/>
                    <measurement group_id="O2" value="17.19" spread="0.25"/>
                    <measurement group_id="O3" value="19.73" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Requiring Rescue Medication After Week 4</title>
        <description>Recording of each dose of approved rescue medication after the Week 4 visit through Week 12</description>
        <time_frame>8 Weeks</time_frame>
        <population>We were unable to complete this analysis due to a misunderstanding on the part of the subjects in the definition of &quot;rescue medication&quot;. It was confirmed across most countries and sites that subjects indicated use of rescue medication mistakenly, thinking they were being asked to report whether they took the study medication. This data could not be fully reconciled and, therefore, no analysis was completed.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Requiring Rescue Medication After Week 4</title>
          <description>Recording of each dose of approved rescue medication after the Week 4 visit through Week 12</description>
          <population>We were unable to complete this analysis due to a misunderstanding on the part of the subjects in the definition of &quot;rescue medication&quot;. It was confirmed across most countries and sites that subjects indicated use of rescue medication mistakenly, thinking they were being asked to report whether they took the study medication. This data could not be fully reconciled and, therefore, no analysis was completed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)</title>
        <description>The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 &quot;component&quot; scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.</description>
        <time_frame>12 Weeks, 24 Weeks</time_frame>
        <population>Full analysis set. Population sizes differ based on number of patients that completed the assessment at each timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)</title>
          <description>The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 &quot;component&quot; scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.</description>
          <population>Full analysis set. Population sizes differ based on number of patients that completed the assessment at each timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.291"/>
                    <measurement group_id="O2" value="-1.48" spread="0.291"/>
                    <measurement group_id="O3" value="-0.91" spread="0.294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" spread="0.292"/>
                    <measurement group_id="O2" value="-1.77" spread="0.294"/>
                    <measurement group_id="O3" value="-1.09" spread="0.301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)</title>
        <description>Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse</description>
        <time_frame>Week 4, Week 24</time_frame>
        <population>Population size at each timepoint differs based on the number of patients that completed the assessment at the timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)</title>
          <description>Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse</description>
          <population>Population size at each timepoint differs based on the number of patients that completed the assessment at the timepoint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="103"/>
                    <count group_id="O3" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="77"/>
                    <measurement group_id="O3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)</title>
        <description>The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.</description>
        <time_frame>Week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)</title>
          <description>The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.31"/>
                    <measurement group_id="O2" value="-0.80" spread="0.31"/>
                    <measurement group_id="O3" value="-0.62" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)</title>
        <description>Change from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.</description>
        <time_frame>24 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)</title>
          <description>Change from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.810"/>
                    <measurement group_id="O2" value="1.65" spread="0.820"/>
                    <measurement group_id="O3" value="1.41" spread="0.834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the SF-36v2 Physical Composite Score (PCS)</title>
        <description>Change from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.</description>
        <time_frame>24 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the SF-36v2 Physical Composite Score (PCS)</title>
          <description>Change from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.37" spread="0.647"/>
                    <measurement group_id="O2" value="3.64" spread="0.652"/>
                    <measurement group_id="O3" value="1.58" spread="0.663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)</title>
        <description>The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.</description>
        <time_frame>24 Weeks</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)</title>
          <description>The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.</description>
          <population>Full Analysis Set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="1.039"/>
                    <measurement group_id="O2" value="1.43" spread="1.055"/>
                    <measurement group_id="O3" value="0.04" spread="1.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Physical Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="1.057"/>
                    <measurement group_id="O2" value="2.64" spread="1.074"/>
                    <measurement group_id="O3" value="0.16" spread="1.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily Pain Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="1.172"/>
                    <measurement group_id="O2" value="4.10" spread="1.185"/>
                    <measurement group_id="O3" value="1.8" spread="1.201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="1.091"/>
                    <measurement group_id="O2" value="2.38" spread="1.119"/>
                    <measurement group_id="O3" value="-1.18" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="1.142"/>
                    <measurement group_id="O2" value="3.35" spread="1.156"/>
                    <measurement group_id="O3" value="1.81" spread="1.168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="1.153"/>
                    <measurement group_id="O2" value="2.05" spread="1.173"/>
                    <measurement group_id="O3" value="1.89" spread="1.181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Emotional Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.11" spread="1.147"/>
                    <measurement group_id="O2" value="1.2" spread="1.169"/>
                    <measurement group_id="O3" value="-0.32" spread="1.178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.92" spread="1.169"/>
                    <measurement group_id="O2" value="0.75" spread="1.188"/>
                    <measurement group_id="O3" value="-0.69" spread="1.194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)</title>
        <description>The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.</description>
        <time_frame>24 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)</title>
          <description>The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.308"/>
                    <measurement group_id="O2" value="-0.80" spread="0.312"/>
                    <measurement group_id="O3" value="-0.62" spread="0.314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™</title>
        <description>The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.</description>
        <time_frame>24 Weeks</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™</title>
          <description>The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.</description>
          <population>Full analysis set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" spread="0.765"/>
                    <measurement group_id="O2" value="2.33" spread="0.768"/>
                    <measurement group_id="O3" value="-1.30" spread="0.793"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)</title>
        <description>The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).</description>
        <time_frame>24 Weeks</time_frame>
        <population>Full Analysis Set. Only VAS Scores analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)</title>
          <description>The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).</description>
          <population>Full Analysis Set. Only VAS Scores analyzed.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.59" spread="1.783"/>
                    <measurement group_id="O2" value="3.97" spread="1.791"/>
                    <measurement group_id="O3" value="-0.35" spread="1.810"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument</title>
        <description>The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).</description>
        <time_frame>24 Weeks</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument</title>
          <description>The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).</description>
          <population>Full Analysis Set</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.016"/>
                    <measurement group_id="O2" value="0.04" spread="0.017"/>
                    <measurement group_id="O3" value="0.01" spread="0.016"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery</title>
        <description>Percentage of subjects indicating that they are willing to consider Sinus Surgery</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery</title>
          <description>Percentage of subjects indicating that they are willing to consider Sinus Surgery</description>
          <population>Full Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention</title>
        <description>Percentage of Subjects who meet the minimal objective criteria for surgical intervention</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention</title>
          <description>Percentage of Subjects who meet the minimal objective criteria for surgical intervention</description>
          <population>Full Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery</title>
        <description>Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.</description>
        <time_frame>Week 24</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery</title>
          <description>Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.</description>
          <population>Full Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).</title>
        <description>The Health and Work Performance Questionnaire measures work productivity (absenteeism and presenteeism). - Absenteeism is measured in missed work days over the past four weeks (range 0-20); absenteeism is measured in % productivity at work (0-100%), with higher values indicating improved productivity. - Presenteeism can be converted to number of days of productive time lost per month, and when added to the number of lost days due to absenteeism provides an estimate of total productive work days lost.</description>
        <time_frame>24 Weeks</time_frame>
        <posting_date>06/2024</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation of Safety by Recording the Severity of Adverse Events (AEs)</title>
        <description>Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe</description>
        <time_frame>24 Weeks</time_frame>
        <population>Safety Analysis Set - Subjects with at least 1 AE</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Safety by Recording the Severity of Adverse Events (AEs)</title>
          <description>Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe</description>
          <population>Safety Analysis Set - Subjects with at least 1 AE</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation of Safety-Nasal Examination</title>
        <description>Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum.</description>
        <time_frame>24 Weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Safety-Nasal Examination</title>
          <description>Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum.</description>
          <population>Safety Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="105"/>
                <count group_id="O3" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Epistaxis</title>
              <category_list>
                <category>
                  <title>Present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Absent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Septal Erosion/Perforation</title>
              <category_list>
                <category>
                  <title>Present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Absent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ulceration/Erosion (non-septum)</title>
              <category_list>
                <category>
                  <title>Present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Absent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="103"/>
                    <measurement group_id="O3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mucosal Candidiasis</title>
              <category_list>
                <category>
                  <title>Present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Absent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="105"/>
                    <measurement group_id="O3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation of Safety Measuring Vital Signs- Blood Pressure</title>
        <description>Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)</description>
        <time_frame>24 Weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Safety Measuring Vital Signs- Blood Pressure</title>
          <description>Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)</description>
          <population>Safety Analysis Set</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.3" spread="14.15"/>
                    <measurement group_id="O2" value="126.7" spread="14.11"/>
                    <measurement group_id="O3" value="127.3" spread="14.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0" spread="8.22"/>
                    <measurement group_id="O2" value="78.2" spread="9.70"/>
                    <measurement group_id="O3" value="79.3" spread="8.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation of Safety Measuring Vital Signs- Pulse</title>
        <description>Measure pulse in beats per minute (bpm)</description>
        <time_frame>24 Weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Safety Measuring Vital Signs- Pulse</title>
          <description>Measure pulse in beats per minute (bpm)</description>
          <population>Safety Analysis Set</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.7" spread="11.96"/>
                    <measurement group_id="O2" value="72.7" spread="9.5"/>
                    <measurement group_id="O3" value="73.1" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation of Safety Measuring Vital Signs- Weight</title>
        <description>Assessment of safety from physical examination-weight measured in kg or lb</description>
        <time_frame>24 Weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Safety Measuring Vital Signs- Weight</title>
          <description>Assessment of safety from physical examination-weight measured in kg or lb</description>
          <population>Safety Analysis Set</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="104"/>
                <count group_id="O3" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.81" spread="20.873"/>
                    <measurement group_id="O2" value="84.23" spread="19.232"/>
                    <measurement group_id="O3" value="83.84" spread="21.531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Evaluation of Safety - Monitoring Concomitant Medication Usage</title>
        <description>Assessment for safety from the collection of information for concomitant medications usage</description>
        <time_frame>24 Weeks</time_frame>
        <population>Number of subjects receiving concomitant medications. Only top 5 con-meds are detailed below.</population>
        <group_list>
          <group group_id="O1">
            <title>OPN-375 186 μg BID</title>
            <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O2">
            <title>OPN-375 372 μg BID</title>
            <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Safety - Monitoring Concomitant Medication Usage</title>
          <description>Assessment for safety from the collection of information for concomitant medications usage</description>
          <population>Number of subjects receiving concomitant medications. Only top 5 con-meds are detailed below.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Amides</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adrenergics in Combination with Corticosteroids or other drugs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ace Inhibitors, Plain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Allergen Extracts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alpha-Adrenoreceptor Antagonists</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Pretreatment (Screening/Run-in) period to end of treatment (Week 24)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>OPN-375 186 μg BID</title>
          <description>OPN-375 186 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
        </group>
        <group group_id="E2">
          <title>OPN-375 372 μg BID</title>
          <description>OPN-375 372 μg BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Matching Placebo BID x 24 Weeks&#xD;
OPN-375: OPN-375, BID</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Alcoholic pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adenomyosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract nuclear</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Cataract cortical</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John Messina, PharmD, SVP of Clinical Research &amp; Medical Affairs</name_or_title>
      <organization>OptiNose</organization>
      <phone>267-521-0565</phone>
      <email>John.Messina@optinose.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03781804
org study id: OPN-FLU-CS-3205
nct id: NCT03781804
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg
      twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without
      nasal polyps.
The primary objective of this study is to compare the efficacy of intranasal administration
      of twice-daily doses of 186 and 372 µg of OPN-375 (fluticasone propionate) with placebo in
      subjects with chronic rhinosinusitis using the following co-primary endpoints:

        1. A change from baseline in symptoms as measured by a composite score of nasal congestion,
           facial pain or pressure sensation, and nasal discharge (anterior and/or posterior) at
           the end of Week 4.

        2. A change from baseline to Week 24/Early Termination (ET) in the average percent of the
           volume opacified in the ethmoid and maxillary sinuses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4
time frame: 4 Weeks
description: Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.
measure: Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses
time frame: Baseline, Week 24
description: Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.
measure: Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains
time frame: Week 24
description: The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem,3=moderate problem, 4=severe problem, 5=problem as bad as it can be.
measure: Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior)
time frame: Week 12
description: Change from baseline in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.
measure: Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores
time frame: 12 Weeks
description: Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours), The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.
measure: Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores
time frame: 12 Weeks
description: Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours) The sense of smell scored as 0= normal, 1=slightly impaired, 2=moderately impaired, 3=absent. The change reported in the results is calculated by subtracting the score reported at Baseline from the score reported at Visit 4 (Week 12).
measure: Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores
time frame: 12 Weeks
description: Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.
measure: Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores
time frame: 12 Weeks
description: Subjects will report both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptom severity over the past 12 hours). The Nasal Symptom Scale scores as 0=none, 1=mild-symptoms clearly present but minimal awareness, and easily tolerated, 2= moderate - definite awareness of symptoms that is bothersome but tolerable, 3 = severe - symptoms that are hard to tolerate, cause interference with activities or daily living.
The value reported in the results is calculated by subtracting the score reported by the patient at Baseline from the score reported by the patient at Visit 4 (Week 12).
measure: Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations
time frame: 24 Weeks
description: Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT for CRS with Nasal Polyps (NP) and without NP sub-groups and in patients with and without previous sinus surgery. Percent volume opacified can range from 0% to 100%. Outcome measure is percentage change from percent opacification at baseline to percent opacification at Week 24; therefor, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.
measure: Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score
time frame: Baseline, Week 24
description: Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for each of the left and right ostiomeatal complex (OMC). The total LM score for a CT scan ranges from 0-24.
measure: Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined
time frame: 24 Weeks
description: Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).
The values reported for this outcome are the change in total opacification of the left and right maxillary and ethmoid sinuses (Visit 6 [Wk 24] score minus Baseline score). Each visit score can range from a total of 0-12 (sum of 0-2 score assigned for each of left and right maxillary, left and right anterior ethmoid, and left and right posterior ethmoid).
measure: Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs
time frame: Week 24
description: Lund-Mackay Staging System: Lund-Mackay (LM) system (Lund and Mackay, 1993) assigns to each of 10 sinus cavities (left and right maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) a score of 0 (no opacification), 1 (partial opacification), or 2 (total opacification), plus a 0-2 score for the ostiomeatal complex (OMC).
Each sinus pair (left and right side) listed below can achieve a total score of 0-4 (sum of 0-2 for each side). The values reported below are calculated by subtracting the total score at Baseline from the total score at Visit 6 (Wk 24).
measure: Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment
time frame: Baseline, Week 24
measure: Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment
time frame: Baseline, Week 24
measure: Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations
time frame: 24 Weeks
description: Percent of sinus volume occupied by disease in the worst sinus between maxillary and ethmoid sinuses for the total population, chronic rhinosinusitis with nasal polyps (CRSwNP) subgroup, chronic rhinosinusitis without nasal polyps (CRSsNP) subgroup, patients with previous sinus surgery subgroup, and without previous surgery subgroup.
measure: Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score
time frame: Baseline, Week 24
description: Zeinrich Modification of the Lund-Mackay Staging System:
Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% for each sinus. Total score ranges from 0 to 50.
measure: Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined
time frame: Baseline, Week 24
description: Zeinrich Modification of the Lund-Mackay Staging System:
Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% The total score for the combined ethmoids and maxillary sinuses can range from 0-30 (0-5 for each left and right of the anterior ethmoid, posterior ethmoid, and maxillary sinuses). The outcome values presented in the results are determined by subtracting the total score at Baseline from the total score at Week 24.
measure: Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs
time frame: Baseline, Week 24
description: Zeinrich Modification of the Lund-Mackay Staging System:
Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100% Each sinus pair (left and right side) listed below can achieve a total score of 0-10 (sum of score on each side). The values reported for this outcome calculated by subtracting the score at Baseline from the score at Visit 6 (Wk 24).
measure: Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations
time frame: Baseline, Week 24
description: Zeinrich Modification of the Lund-Mackay Staging System:
Zeinrich modified the LM system by creating subdivisions within "partial opacification" and increasing the range of scores to 0-5 based on percent opacification: 0 = 0%, 1 = 1%-25%, 2 = 26%-50%, 3 = 51%-75%, 4 = 76%- 99%, and 5 = 100%
measure: Time Comparison to First Acute Exacerbation of Chronic Sinusitis
time frame: 24 Weeks
description: Comparing the distribution of time to first acute exacerbation of chronic sinusitis, defined as a worsening of symptoms that requires escalation of treatment
measure: Percentage of Subjects Requiring Rescue Medication After Week 4
time frame: 8 Weeks
description: Recording of each dose of approved rescue medication after the Week 4 visit through Week 12
measure: Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
time frame: 12 Weeks, 24 Weeks
description: The PSQI is a validated, self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate 7 "component" scores (each ranging between 0 and 3): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging between 0 and 21. Higher values represent a worse outcome.
measure: Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)
time frame: Week 4, Week 24
description: Global impression of change will be assessed using a subject-completed PGIC scale range: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse
measure: Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)
time frame: Week 24
description: The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, where higher scores indicate a worse outcome.
measure: Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)
time frame: 24 Weeks
description: Change from baseline to Week 24/ET on the MCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
measure: Change in the SF-36v2 Physical Composite Score (PCS)
time frame: 24 Weeks
description: Change from baseline to Week 24/ET on the PCS of the 36-Item Short Form Health Survey version 2 (SF-36v2). The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire. The scale range is from 0-100. A lower score means more disability and a higher score means less disability.
measure: Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)
time frame: 24 Weeks
description: The SF-36v2 is a multipurpose, 36-item subject-completed validated questionnaire that measures 8 domains of health: physical functioning, role limitations due to physical health (RP), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 survey with a 4-week recall will be used. It yields scale scores for each of these 8 health domains , each of which is scored from 0 to 100. Higher scores indicate with a better health status, with 100 representing the highest level of functioning possible.
measure: Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)
time frame: 24 Weeks
description: The 16-item QIDS (Rush et al. 2003) is designed to assess the severity of depressive symptoms. The QIDS is available in a self-rated version and assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 5th edition to diagnose a major depressive episode. The 7-day period prior to assessment is the usual time frame for assessing symptom severity. Scores range from 0 to 27, with higher scores indicating a worse outcome.
measure: Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™
time frame: 24 Weeks
description: The SIT is a test comprised of 4 booklets each containing 10 microencapsulated (scratch and sniff) odors. Forced choice response alternatives to identify the odor accompany each test item. Each correct response is assigned a score of 1 and incorrect responses are assigned a score of 0. The total score is calculated by summing the scores of each individual odor for a total possible score ranging from 0-40. The higher the score, the better the individual's sense of smell. The test provides an absolute indication of smell loss (anosmia; mild, moderate or severe hyposmia) as well as an index to detect malingering.
measure: Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)
time frame: 24 Weeks
description: The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The outcome measured for this study was the EQ VAS, which records the subject's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the subject's own judgement. VAS scores range from 0 (worst health you can imagine) to 100 (best health you can imagine).
measure: Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument
time frame: 24 Weeks
description: The SF-6D is a single health state index derived from the 11 items from the SF-36v2. SF-6D scores range from 0 (worst health state) to 1 (best health state).
measure: Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery
time frame: Baseline, Week 24
description: Percentage of subjects indicating that they are willing to consider Sinus Surgery
measure: Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention
time frame: Baseline, Week 24
description: Percentage of Subjects who meet the minimal objective criteria for surgical intervention
measure: Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery
time frame: Week 24
description: Outcome value presented here is the percent of subjects who are approved for surgery but no longer elect to undergo a surgery. The number of participants analyzed indicates the total number of participants for whom this analysis was completed.
measure: Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).
time frame: 24 Weeks
description: The Health and Work Performance Questionnaire measures work productivity (absenteeism and presenteeism). - Absenteeism is measured in missed work days over the past four weeks (range 0-20); absenteeism is measured in % productivity at work (0-100%), with higher values indicating improved productivity. - Presenteeism can be converted to number of days of productive time lost per month, and when added to the number of lost days due to absenteeism provides an estimate of total productive work days lost.
measure: Evaluation of Safety by Recording the Severity of Adverse Events (AEs)
time frame: 24 Weeks
description: Assessment of safety by measuring severity of AEs using scale with 1=mild, 2=moderate, 3=severe
measure: Evaluation of Safety-Nasal Examination
time frame: 24 Weeks
description: Assessed in nasal examination worksheet which includes recording the presence of any epistaxis, septal erosion/perforation, ulceration/erosion of area other than septum.
measure: Evaluation of Safety Measuring Vital Signs- Blood Pressure
time frame: 24 Weeks
description: Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
measure: Evaluation of Safety Measuring Vital Signs- Pulse
time frame: 24 Weeks
description: Measure pulse in beats per minute (bpm)
measure: Evaluation of Safety Measuring Vital Signs- Weight
time frame: 24 Weeks
description: Assessment of safety from physical examination-weight measured in kg or lb
measure: Evaluation of Safety - Monitoring Concomitant Medication Usage
time frame: 24 Weeks
description: Assessment for safety from the collection of information for concomitant medications usage
arm group label: OPN-375 186 μg BID
arm group type: Active Comparator
description: OPN-375 186 μg BID x 24 Weeks
arm group label: OPN-375 372 μg BID
arm group type: Active Comparator
description: OPN-375 372 μg BID x 24 Weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching Placebo BID x 24 Weeks
intervention type: Drug
intervention name: OPN-375
description: OPN-375, BID
arm group label: OPN-375 186 μg BID
arm group label: OPN-375 372 μg BID
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Carothers
role: Study Director
affiliation: Optinose US Inc.
last name: John Messina
role: Study Chair
affiliation: Optinose US Inc.
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country: Bulgaria
country: Canada
country: Georgia
country: Poland
country: Russian Federation
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Nasal Polyps
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