<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/NCT02260492</url>
  </required_header>
  <id_info>
    <org_study_id>OTT329/305</org_study_id>
    <nct_id>NCT02260492</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma</brief_title>
  <official_title>Clinical Endpoint Study of Salmeterol Xinafoate/Fluticasone Propionate Combination for Comparison of a Test and Reference Product in Patients With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oriel Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oriel Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to establish the equivalence of OT329 Solis and Advair Diskus when&#xD;
      administered by inhalation in patients with asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Serial FEV1-time Curve (AUC 0-12h)</measure>
    <time_frame>0-12 hours after dosing on Day 1</time_frame>
    <description>Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1 Trough</measure>
    <time_frame>Post-4 weeks of treatment</time_frame>
    <description>Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>From Screen (Day -28) until 1 week post last treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">879</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>OT329 Solis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OT329 Solis (twice daily inhalation throughout the study)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Advair Diskus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Advair Diskus (twice daily inhalation throughout the study)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (twice daily inhalation throughout the study)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OT329 (combination of fluticasone propionate and salmeterol xinafoate)</intervention_name>
    <description>Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler</description>
    <arm_group_label>OT329 Solis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)</intervention_name>
    <description>Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler</description>
    <arm_group_label>Advair Diskus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (lactose) administered via the Solis dry powder inhaler</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females ≥ 18 years old of non-child bearing potential or of child bearing&#xD;
             potential committing to consistent and correct use of an acceptable method of birth&#xD;
             control&#xD;
&#xD;
          2. Subjects with a reliable clinical history of asthma documented at least 12 weeks prior&#xD;
             to screening&#xD;
&#xD;
          3. Subjects with a pre-bronchodilator FEV1 of &gt; 40% and &lt;85% of the predicted value&#xD;
             during the screening visit and on the first day of treatment&#xD;
&#xD;
          4. Subjects who are currently non-smoking and have not used tobacco products (i.e.,&#xD;
             cigarettes, cigars, pipe tobacco) within the past year, and had &lt; 10 pack-years of&#xD;
             historical use&#xD;
&#xD;
          5. Subjects with &gt; 15% reversibility of FEV1 within 30 minutes following 360 mcg of&#xD;
             albuterol inhalation (pMDI). Note: This test may be repeated on a different day if the&#xD;
             patient fails the first attempt; and if the patient achieves at least 10%&#xD;
             reversibility and the Investigator thinks that a second attempt is appropriate&#xD;
&#xD;
          6. Subjects who are able to discontinue their asthma medications (inhaled corticosteroids&#xD;
             and long-acting beta agonists) during the run-in period and for the remainder of the&#xD;
             study&#xD;
&#xD;
          7. Subjects who are able to replace current short-acting beta agonists (SABAs) with&#xD;
             salbutamol/albuterol inhaler for use as needed for the duration of the study (subjects&#xD;
             should be able to withhold all inhaled SABAs for at least 6 hours prior to lung&#xD;
             function assessments on study visits)&#xD;
&#xD;
          8. Subjects who are able to continue the following medications without a significant&#xD;
             adjustment of dosage, formulation, or dosing interval for the duration of the study,&#xD;
             and judged able by the investigator to withhold them for the specified minimum time&#xD;
             intervals prior to each clinic visit: short-acting forms of theophylline for 12 hours,&#xD;
             twice-a-day controlled release forms of theophylline for 24 hours, once-a-day&#xD;
             controlled-release forms of theophylline for 36 hours&#xD;
&#xD;
          9. Subjects who are able to discontinue the following medications for the specified&#xD;
             minimum time intervals prior to the run-in period and for the remainder of the study:&#xD;
             oral and parenteral corticosteroids for 1 month and oral short-acting beta agonists&#xD;
             for 12 hours&#xD;
&#xD;
         10. Subjects who are able and willing to give their written informed consent to&#xD;
             participate in the study.&#xD;
&#xD;
             **********************************************************&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
         11. Female Subjects who are pregnant or breastfeeding&#xD;
&#xD;
         12. Subjects who have life-threatening asthma in the last 10 years, as defined as a&#xD;
             history of asthma episode(s) requiring intubation, and/or associated with&#xD;
             hypercapnoea; respiratory arrest or hypoxic seizures, asthma-related syncopal&#xD;
             episodes(s), or hospitalizations within the past year or during the run-in period&#xD;
&#xD;
         13. Subjects with evidence or history of clinically significant disease or abnormality&#xD;
             including congestive heart failure, uncontrolled hypertension, uncontrolled coronary&#xD;
             artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical&#xD;
             or current evidence of significant hematologic, hepatic, neurologic, psychiatric,&#xD;
             renal, or other diseases that in the opinion of the investigator, would put the&#xD;
             patient at risk through study participation, or would affect the study analyses if the&#xD;
             disease exacerbated during the study&#xD;
&#xD;
         14. Subjects with a hypersensitivity to any sympathomimetic drug (e.g. Salmeterol or&#xD;
             salbutamol/albuterol) or any inhaled, intranasal or systemic corticosteroid therapy&#xD;
&#xD;
         15. Subjects who are on other medications with the potential to affect the course of&#xD;
             asthma or to interact with sympathomimetic amines (e.g. beta blockers, oral&#xD;
             decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants,&#xD;
             monoamine oxidase inhibitors)&#xD;
&#xD;
         16. Subjects with a viral or bacterial upper or lower respiratory tract infection or sinus&#xD;
             or middle ear infection within 4 weeks prior to the screening visit or during the&#xD;
             run-in period&#xD;
&#xD;
         17. Subjects with any factors (e.g. infirmity, disability, or geographic location) that&#xD;
             the investigator feel would likely limit the patient's compliance with the study&#xD;
             protocol or scheduled clinic visits&#xD;
&#xD;
         18. Subjects who have used any investigational drug in any clinical trial within 1 month&#xD;
             of receiving the first dose of OT329 Solis™ study medication&#xD;
&#xD;
         19. Subjects who cannot communicate reliably or who are unlikely to co-operate with the&#xD;
             requirements of the study, in the opinion of the Investigator&#xD;
&#xD;
         20. Subjects with a milk protein allergy&#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>Rick Fuller, MD FRCP</last_name>
    <role>Study Director</role>
    <affiliation>Oriel Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85395</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Invetigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Homestead</city>
        <state>Florida</state>
        <zip>33030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Kissimee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>New Port Richie</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Therapeutics Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <zip>08558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Rock Hill</city>
        <state>South Carolina</state>
        <zip>29732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oriel Investigative Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>February 10, 2017</results_first_submitted>
  <results_first_submitted_qc>March 28, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 15, 2017</results_first_posted>
  <last_update_submitted>March 28, 2017</last_update_submitted>
  <last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</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>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Salmeterol Xinafoate</mesh_term>
    <mesh_term>Fluticasone-Salmeterol Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Results delayed pending FDA review/approval of drug.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>1526 Patients with asthma were screened at 48 clinical sites</recruitment_details>
      <pre_assignment_details>647 Failed screening (42%)&#xD;
239 failed because they did not have 40-85% pred FEV1&#xD;
240 failed because they were not &gt;15% reversible with albuterol&#xD;
168 failed for other inclusion/exclusion criteria</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>OT329 Solis</title>
          <description>OT329 Solis (twice daily inhalation throughout the study)&#xD;
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler</description>
        </group>
        <group group_id="P2">
          <title>Advair Diskus</title>
          <description>Advair Diskus (twice daily inhalation throughout the study)&#xD;
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo (twice daily inhalation throughout the study)&#xD;
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="418"/>
                <participants group_id="P2" count="419"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Day 1</title>
              <participants_list>
                <participants group_id="P1" count="418"/>
                <participants group_id="P2" count="419"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="395"/>
                <participants group_id="P2" count="406"/>
                <participants group_id="P3" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <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="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-Treat (ITT)</population>
      <group_list>
        <group group_id="B1">
          <title>OT329 Solis</title>
          <description>OT329 Solis (twice daily inhalation throughout the study)&#xD;
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler</description>
        </group>
        <group group_id="B2">
          <title>Advair Diskus</title>
          <description>Advair Diskus (twice daily inhalation throughout the study)&#xD;
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo (twice daily inhalation throughout the study)&#xD;
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler</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="418"/>
            <count group_id="B2" value="419"/>
            <count group_id="B3" value="42"/>
            <count group_id="B4" value="879"/>
          </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="43.9" spread="14.52"/>
                    <measurement group_id="B2" value="43.3" spread="14.26"/>
                    <measurement group_id="B3" value="43.2" spread="15.25"/>
                    <measurement group_id="B4" value="43.6" spread="14.42"/>
                  </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="274"/>
                    <measurement group_id="B2" value="251"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="555"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="324"/>
                  </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="122"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="249"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="296"/>
                    <measurement group_id="B2" value="301"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="630"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                  </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="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="332"/>
                    <measurement group_id="B2" value="308"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="669"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="22"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="418"/>
                    <measurement group_id="B2" value="419"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kg)</title>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.5" spread="22.9"/>
                    <measurement group_id="B2" value="85.9" spread="23.1"/>
                    <measurement group_id="B3" value="81.0" spread="17.2"/>
                    <measurement group_id="B4" value="86.9" spread="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height (cm)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.5" spread="9.9"/>
                    <measurement group_id="B2" value="169.2" spread="10.7"/>
                    <measurement group_id="B3" value="166.3" spread="8.3"/>
                    <measurement group_id="B4" value="168.2" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.49" spread="7.61"/>
                    <measurement group_id="B2" value="29.91" spread="7.20"/>
                    <measurement group_id="B3" value="29.32" spread="6.30"/>
                    <measurement group_id="B4" value="30.63" spread="7.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Airways Reversibility with Albuterol</title>
          <description>Patients were screened for their airways reversibility following albuterol. Baseline FEV1 was measured then the patient received 360 mcg of albuterol (pMDI), a short-acting adrenergic agonist. Within 30 min of albuterol administration, lung function was measured again. Inclusion Criteria #5 required at least 15% reversibility or improvement in FEV1.</description>
          <units>% change from pre-albuterol lung functio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.5" spread="19.3"/>
                    <measurement group_id="B2" value="29.7" spread="17.5"/>
                    <measurement group_id="B3" value="25.9" spread="13.3"/>
                    <measurement group_id="B4" value="29.9" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Serial FEV1-time Curve (AUC 0-12h)</title>
        <description>Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.</description>
        <time_frame>0-12 hours after dosing on Day 1</time_frame>
        <population>Intent-to-treat (ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>OT329 Solis</title>
            <description>OT329 Solis (twice daily inhalation throughout the study)&#xD;
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler</description>
          </group>
          <group group_id="O2">
            <title>Advair Diskus</title>
            <description>Advair Diskus (twice daily inhalation throughout the study)&#xD;
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (twice daily inhalation throughout the study)&#xD;
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serial FEV1-time Curve (AUC 0-12h)</title>
          <description>Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.</description>
          <population>Intent-to-treat (ITT)</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="418"/>
                <count group_id="O2" value="419"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.610" spread="9.044"/>
                    <measurement group_id="O2" value="30.151" spread="9.107"/>
                    <measurement group_id="O3" value="27.270" spread="7.710"/>
                  </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>
            <groups_desc>Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:&#xD;
H01: uT-uR &lt; -0.20 uR vs. Ha1: -0.20 uR &lt;/= uT- uR (the lower tail) and H02: uT-uR &gt;0.25 uR vs. Ha2: uT- uR &lt;/=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.&#xD;
Superiority test compares Test with Placebo (p&lt;0.05) Superiority test compares Reference with Placebo (p&lt;0.05) (p&lt;0.05)</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Test/Reference</param_type>
            <param_value>1.0799</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.8</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
            <other_analysis_desc>Day 1 superiority to placebo:&#xD;
Solis vs. Placebo p=0.004 Advair vs. Placebo p=0.012</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FEV1 Trough</title>
        <description>Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.</description>
        <time_frame>Post-4 weeks of treatment</time_frame>
        <population>Intent-to-Treat</population>
        <group_list>
          <group group_id="O1">
            <title>OT329 Solis</title>
            <description>OT329 Solis (twice daily inhalation throughout the study)&#xD;
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler</description>
          </group>
          <group group_id="O2">
            <title>Advair Diskus</title>
            <description>Advair Diskus (twice daily inhalation throughout the study)&#xD;
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (twice daily inhalation throughout the study)&#xD;
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler</description>
          </group>
        </group_list>
        <measure>
          <title>FEV1 Trough</title>
          <description>Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.</description>
          <population>Intent-to-Treat</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="395"/>
                <count group_id="O2" value="406"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.516" spread="0.792"/>
                    <measurement group_id="O2" value="2.579" spread="0.774"/>
                    <measurement group_id="O3" value="2.323" spread="0.736"/>
                  </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>
            <groups_desc>Same as the Day 1 analyses</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Standard bioequivalence 90% confidence bounds set at 0.8-1.25.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>ANOVA</method>
            <param_type>Test/Reference</param_type>
            <param_value>1.0475</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.8</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
            <other_analysis_desc>Week 4 superiority to placebo:&#xD;
Solis vs. Placebo p=0.019 Advair vs. Placebo p=0.035</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <time_frame>From Screen (Day -28) until 1 week post last treatment</time_frame>
        <population>One subject who was assigned OT329 SOLIS received placebo treatment kit in error. The mistake was discovered on Day 1 and the patient was removed from the study. The patient was included in the OT329 SOLIS group for the intent-to-treat analysis but was put in the Placebo group for the Safety analysis as defined by the Statisical Analysis Plan.</population>
        <group_list>
          <group group_id="O1">
            <title>OT329 Solis</title>
            <description>OT329 Solis (twice daily inhalation throughout the study)&#xD;
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler</description>
          </group>
          <group group_id="O2">
            <title>Advair Diskus</title>
            <description>Advair Diskus (twice daily inhalation throughout the study)&#xD;
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (twice daily inhalation throughout the study)&#xD;
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <population>One subject who was assigned OT329 SOLIS received placebo treatment kit in error. The mistake was discovered on Day 1 and the patient was removed from the study. The patient was included in the OT329 SOLIS group for the intent-to-treat analysis but was put in the Placebo group for the Safety analysis as defined by the Statisical Analysis Plan.</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="417"/>
                <count group_id="O2" value="418"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from time of consent until 1 week post last treatment, up to 5 weeks. Adverse events from screen failed subjects are omitted.</time_frame>
      <desc>Treatment emergent adverse events are reported from Day 1 of treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>OT329 Solis</title>
          <description>OT329 Solis (twice daily inhalation throughout the study)&#xD;
OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler</description>
        </group>
        <group group_id="E2">
          <title>Advair Diskus</title>
          <description>Advair Diskus (twice daily inhalation throughout the study)&#xD;
Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo (twice daily inhalation throughout the study)&#xD;
Placebo: Placebo (lactose) administered via the Solis dry powder inhaler</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-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="417"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="419"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="417"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="419"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <description>Fatal heart attack</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="417"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>H. pylori infection</sub_title>
                <description>H. pylori gastrointestinal infection leading to hospitalization</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="417"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-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="52" subjects_at_risk="417"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="419"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="417"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="417"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="417"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="417"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="417"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="417"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="417"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="417"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="417"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="417"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="417"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="417"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="417"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="417"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="419"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="417"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="419"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="43"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>One patient was randomized to OT329 SOLIS treatment but was given a Placebo kit in error. They are included in the SOLIS group for the efficacy analysis and in the Placebo group for the safety analysis as dictated by the Statistical Analysis Plan.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Malinda Longphre PhD, Director Clinical Reserach</name_or_title>
      <organization>Oriel Therapeutics, a Novartis Company</organization>
      <phone>9193131290 ext 114</phone>
      <email>mlongphre@orieltherapeutics.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/NCT02260492
org study id: OTT329/305
nct id: NCT02260492
lead sponsor: 
has dmc: No
This is a study to establish the equivalence of OT329 Solis and Advair Diskus when
      administered by inhalation in patients with asthma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Area Under the Serial FEV1-time Curve (AUC 0-12h)
time frame: 0-12 hours after dosing on Day 1
description: Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.
measure: FEV1 Trough
time frame: Post-4 weeks of treatment
description: Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.
measure: Number of Participants With Adverse Events
time frame: From Screen (Day -28) until 1 week post last treatment
arm group label: OT329 Solis
arm group type: Experimental
description: OT329 Solis (twice daily inhalation throughout the study)
arm group label: Advair Diskus
arm group type: Active Comparator
description: Advair Diskus (twice daily inhalation throughout the study)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (twice daily inhalation throughout the study)
intervention type: Drug
intervention name: OT329 (combination of fluticasone propionate and salmeterol xinafoate)
description: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler
arm group label: OT329 Solis
intervention type: Drug
intervention name: Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)
description: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler
arm group label: Advair Diskus
intervention type: Drug
intervention name: Placebo
description: Placebo (lactose) administered via the Solis dry powder inhaler
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rick Fuller, MD FRCP
role: Study Director
affiliation: Oriel Therapeutics
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country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
mesh term: Salmeterol Xinafoate
mesh term: Fluticasone-Salmeterol Drug Combination
sharing ipd: Yes
ipd description: Results delayed pending FDA review/approval of drug.
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limitations and caveats: One patient was randomized to OT329 SOLIS treatment but was given a Placebo kit in error. They are included in the SOLIS group for the efficacy analysis and in the Placebo group for the safety analysis as dictated by the Statistical Analysis Plan.
point of contact: 