<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/NCT03005067</url>
  </required_header>
  <id_info>
    <org_study_id>205684</org_study_id>
    <nct_id>NCT03005067</nct_id>
  </id_info>
  <brief_title>To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold</brief_title>
  <official_title>A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Subjects With Symptoms of Common Cold</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study will be conducted in adult participants with symptoms of common cold assessing if&#xD;
      1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo.&#xD;
      The study will also evaluate the safety of 1146A compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a multi-center, randomized, parallel-group, double blind, 2-arm, placebo&#xD;
      controlled study to evaluate the efficacy and safety of 1146A in adult participants with&#xD;
      symptomatic common cold in an outpatient setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">June 7, 2017</completion_date>
  <primary_completion_date type="Actual">June 7, 2017</primary_completion_date>
  <phase>Phase 2</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>Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)</measure>
    <time_frame>Up to Day 4 (Day 1 to 4)</time_frame>
    <description>The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)</measure>
    <time_frame>Up to Day 7 (Day 1 to 7)</time_frame>
    <description>The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Total Symptom Score Over Days 1-4 (ATSS1-4)</measure>
    <time_frame>Up to Day 4 (Day 1 to 4)</time_frame>
    <description>The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Total Symptom Score Over Days 1-7 (ATSS1-7)</measure>
    <time_frame>Up to Day 7 (Day 1 to 7)</time_frame>
    <description>The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>Carbomer 980 (1146A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbomer 980 (1146A)</intervention_name>
    <description>Test product containing carbomer 980 gel</description>
    <arm_group_label>Carbomer 980 (1146A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Reference product containing vehicle without carbomer 980 gel</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Demonstrates understanding of the study procedures, restrictions and willingness to&#xD;
             participate as evidenced by voluntary written informed consent and has received a&#xD;
             signed and dated copy of the informed consent form.&#xD;
&#xD;
          -  Aged between 18 to 75 years inclusive.&#xD;
&#xD;
          -  Male or female.&#xD;
&#xD;
          -  Good general and mental health with, in the opinion of the Investigator or medically&#xD;
             qualified designee no clinically significant and relevant abnormalities in medical&#xD;
             history or upon physical and Investigator-led nasal examination.&#xD;
&#xD;
          -  Females of childbearing potential who are, in the opinion of the Investigator,&#xD;
             practicing a reliable method of contraception. Adequate contraception is defined as&#xD;
             abstinence, oral contraceptive, either combined or progestogen alone OR injectable&#xD;
             progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous&#xD;
             contraceptive patches OR intrauterine device or intrauterine system OR double barrier&#xD;
             method (condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal&#xD;
             agent (foam, gel, film, cream, suppository)) OR male partner sterilization prior to&#xD;
             the female participant's entry into the study, and this male is the sole partner for&#xD;
             that participant.&#xD;
&#xD;
          -  Investigator confirmed diagnosis of symptomatic common cold with an onset of less than&#xD;
             48 hours prior to randomization. Symptomatic common cold is defined as TSS &gt; 9 AND a&#xD;
             score &gt;1 for at least one of the following symptoms: sore throat, runny nose, or&#xD;
             blocked nose.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who have a positive urine pregnancy test.&#xD;
&#xD;
          -  Women who are breast-feeding.&#xD;
&#xD;
          -  During the entire study (Screening - last participant visit):&#xD;
&#xD;
          -  A. Participant who have used medications or therapies that could interfere with study&#xD;
             evaluations and have not had the proper washout period from these medications or&#xD;
             therapies or are anticipated to require any concomitant intranasal medication during&#xD;
             that period or at any time throughout the study.&#xD;
&#xD;
          -  B. Nasal disease(s) likely to affect deposition of intranasal medication, such as&#xD;
             chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or&#xD;
             clinically significant nasal structural abnormalities.&#xD;
&#xD;
          -  C. Nasal surgery or sinus surgery within the previous year.&#xD;
&#xD;
          -  D. Any condition that prohibits the participant from actuating nasal spray devices&#xD;
             (severe rheumatoid arthritis; deformed hands and fingers; missing fingers).&#xD;
&#xD;
          -  E. Clinically relevant abnormal physical findings which, in the opinion of the&#xD;
             Investigator or sponsor's medical monitor, would interfere with the objectives of the&#xD;
             study or that may preclude compliance with the study procedures.&#xD;
&#xD;
          -  F. Uncontrolled cardiovascular, pulmonary, renal, hepatic, gastrointestinal,&#xD;
             hematological, endocrine, metabolic, autoimmune, neurological, psychiatric or other&#xD;
             diseases at screening that would interfere with the study in the opinion of the&#xD;
             Investigator.&#xD;
&#xD;
          -  G. Participants with seasonal allergic rhinitis if randomization occurs during their&#xD;
             expected allergy season or perennial allergic rhinitis.&#xD;
&#xD;
          -  H. Severe COPD, persistent asthma, or recent COPD/asthma exacerbation.&#xD;
&#xD;
          -  I. An inability to comprehend and satisfactorily use the measurement instruments as&#xD;
             determined by the study sites staff on screening.&#xD;
&#xD;
          -  J. Participants with a fever &gt; 38°C (100.4°F).&#xD;
&#xD;
          -  K. Frequent uses of analgesics (i.e. have taken an analgesic for pain in headache and&#xD;
             pain in muscle/joints for at least 1 dose per week on average over the past 6 months).&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to any of the study medications,&#xD;
             excipients or investigational device material or to medications of similar chemical&#xD;
             classes, any history of drug hypersensitivity or other significant allergic diathesis&#xD;
             that could affect study participation and known or suspected contraindications,&#xD;
             including history of allergy or photosensitivity to study medication/s.&#xD;
&#xD;
          -  Participation in another clinical study (including cosmetic studies) or receipt of an&#xD;
             investigational drug within 30 days of the screening visit or 5 half-lives of&#xD;
             enrollment, whichever is longer and previous participation in this study (i.e.&#xD;
             participants cannot be re-screened or randomized).&#xD;
&#xD;
        Recent history (within the last 5 years) of alcohol or other substance abuse and positive&#xD;
        urine drug screen.&#xD;
&#xD;
          -  An employee of the sponsor or the study sites or members of their immediate family and&#xD;
             persons directly or indirectly involved in the execution of this protocol, including&#xD;
             employees of the contract research organization (CRO) and persons related to them.&#xD;
&#xD;
          -  On nasal examination by Investigator, the presence of nasal disease likely to affect&#xD;
             deposition of intranasal treatment or any superficial or moderate nasal mucosal&#xD;
             erosion, nasal mucosal ulceration, or nasal septum perforation at the screening visit.&#xD;
             Participants with difficulty in using the nasal spray applicator, &quot;vulnerable&quot;&#xD;
             individual (as defined by the IRB e.g. incarcerated person) and any condition not&#xD;
             identified in the protocol that in the opinion of the Investigator would confound the&#xD;
             evaluation and interpretation of the study data or may put the participant at risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Elkhorn</city>
        <state>Nebraska</state>
        <zip>68022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fremont</city>
        <state>Nebraska</state>
        <zip>68025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vineland</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hatboro</city>
        <state>Pennsylvania</state>
        <zip>19040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>April 25, 2018</results_first_submitted>
  <results_first_submitted_qc>June 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2018</results_first_posted>
  <last_update_submitted>June 15, 2018</last_update_submitted>
  <last_update_submitted_qc>June 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</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>Common Cold</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>May 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03005067/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>August 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03005067/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from 24 centers in United States.</recruitment_details>
      <pre_assignment_details>A total of 308 participants were screened for this study, out of which137 participants were screening failure.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test Product</title>
          <description>Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).</description>
        </group>
        <group group_id="P2">
          <title>Placebo Nasal Spray</title>
          <description>Participants were administered placebo nasal spray containing vehicle without carbomer 980.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (reason not specified)</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline parameters were reported for safety population. Safety population (N=168) included all randomized participants who received at least one dose of study medication.Three participants were randomized but not dosed, therefore not included in safety population.</population>
      <group_list>
        <group group_id="B1">
          <title>Test Product</title>
          <description>Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).</description>
        </group>
        <group group_id="B2">
          <title>Placebo Nasal Spray</title>
          <description>Participants were administered placebo nasal spray containing vehicle without carbomer 980.</description>
        </group>
        <group group_id="B3">
          <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="87"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="168"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.8" spread="13.99"/>
                    <measurement group_id="B2" value="50.3" spread="12.60"/>
                    <measurement group_id="B3" value="50.1" spread="13.30"/>
                  </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="57"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="55"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="104"/>
                  </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_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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)</title>
        <description>The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.</description>
        <time_frame>Up to Day 4 (Day 1 to 4)</time_frame>
        <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).</description>
          </group>
          <group group_id="O2">
            <title>Placebo Nasal Spray</title>
            <description>Participants were administered placebo nasal spray containing vehicle without carbomer 980.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)</title>
          <description>The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.</description>
          <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.428" spread="1.4784"/>
                    <measurement group_id="O2" value="3.336" spread="1.6917"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.516</p_value>
            <p_value_desc>P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.137</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.279</ci_lower_limit>
            <ci_upper_limit>0.553</ci_upper_limit>
            <estimate_desc>Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)</title>
        <description>The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.</description>
        <time_frame>Up to Day 7 (Day 1 to 7)</time_frame>
        <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).</description>
          </group>
          <group group_id="O2">
            <title>Placebo Nasal Spray</title>
            <description>Participants were administered placebo nasal spray containing vehicle without carbomer 980.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)</title>
          <description>The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.</description>
          <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.700" spread="1.3142"/>
                    <measurement group_id="O2" value="2.651" spread="1.5455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Total Symptom Score Over Days 1-4 (ATSS1-4)</title>
        <description>The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.</description>
        <time_frame>Up to Day 4 (Day 1 to 4)</time_frame>
        <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).</description>
          </group>
          <group group_id="O2">
            <title>Placebo Nasal Spray</title>
            <description>Participants were administered placebo nasal spray containing vehicle without carbomer 980.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Total Symptom Score Over Days 1-4 (ATSS1-4)</title>
          <description>The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.</description>
          <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.811" spread="3.1962"/>
                    <measurement group_id="O2" value="7.754" spread="3.4996"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Total Symptom Score Over Days 1-7 (ATSS1-7)</title>
        <description>The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.</description>
        <time_frame>Up to Day 7 (Day 1 to 7)</time_frame>
        <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).</description>
          </group>
          <group group_id="O2">
            <title>Placebo Nasal Spray</title>
            <description>Participants were administered placebo nasal spray containing vehicle without carbomer 980.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Total Symptom Score Over Days 1-7 (ATSS1-7)</title>
          <description>The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.</description>
          <population>Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.171" spread="2.9822"/>
                    <measurement group_id="O2" value="6.195" spread="3.2078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 8 days</time_frame>
      <desc>All treatment emergent adverse events and serious adverse were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Test Product</title>
          <description>Participants were administered test product (nasal spray) containing carbomer 980 gel (1146A).</description>
        </group>
        <group group_id="E2">
          <title>Placebo Nasal Spray</title>
          <description>Participants were administered placebo nasal spray containing vehicle without carbomer 980.</description>
        </group>
      </group_list>
      <serious_events>
        <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="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>BIPOLAR DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <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="32" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>LACRIMATION INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>RETCHING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ADMINISTRATION SITE PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>APPLICATION SITE PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>CHEST DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>FEELING COLD</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>FEELING JITTERY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ABSCESS OF EYELID</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>LARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>TOOTH INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>VULVOVAGINAL MYCOTIC INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>BACK INJURY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>EXCORIATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD PRESSURE SYSTOLIC INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>BURNING SENSATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>SINUS HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>SOMNOLENCE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>PREGNANCY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>PRODUCT TASTE ABNORMAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>BIPOLAR DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>POLLAKIURIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>RHINORRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>SNEEZING</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>NASAL DRYNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>WHEEZING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>NASAL DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>INTRANASAL HYPOAESTHESIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>NASAL MUCOSAL EROSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>NASAL MUCOSAL ULCER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>RHINALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>SEBORRHOEIC DERMATITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="81"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.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/NCT03005067
org study id: 205684
nct id: NCT03005067
lead sponsor: 
This study will be conducted in adult participants with symptoms of common cold assessing if
      1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo.
      The study will also evaluate the safety of 1146A compared to placebo.
This will be a multi-center, randomized, parallel-group, double blind, 2-arm, placebo
      controlled study to evaluate the efficacy and safety of 1146A in adult participants with
      symptomatic common cold in an outpatient setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)
time frame: Up to Day 4 (Day 1 to 4)
description: The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.
measure: Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)
time frame: Up to Day 7 (Day 1 to 7)
description: The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.
measure: Average Total Symptom Score Over Days 1-4 (ATSS1-4)
time frame: Up to Day 4 (Day 1 to 4)
description: The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.
measure: Average Total Symptom Score Over Days 1-7 (ATSS1-7)
time frame: Up to Day 7 (Day 1 to 7)
description: The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.
arm group label: Carbomer 980 (1146A)
arm group type: Experimental
description: Participants will be administered test product (nasal spray) containing carbomer 980 gel. Three actuations per nostril per dose will be applied, each actuation will be 140µL (microliters) i.e. equivalent to 140mg.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980. Three actuations of placebo nasal spray per nostril per dose; each actuation will be 140µL.
intervention type: Drug
intervention name: Carbomer 980 (1146A)
description: Test product containing carbomer 980 gel
arm group label: Carbomer 980 (1146A)
intervention type: Other
intervention name: Placebo
description: Reference product containing vehicle without carbomer 980 gel
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: United States
responsible party type: Sponsor
mesh term: Common Cold
provided document: 
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certain agreements: 
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