<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/NCT02245672</url>
  </required_header>
  <id_info>
    <org_study_id>MGR001-3001</org_study_id>
    <nct_id>NCT02245672</nct_id>
  </id_info>
  <brief_title>MGR001 / Advair Diskus Local Equivalence Study in Asthma</brief_title>
  <official_title>A Randomized, Double-blind, Double Dummy, Parallel Group Study to Determine the Local Equivalence of Multiple Doses of MGR001 to Advair Diskus Administered Via Oral Inhalation in Adult Asthma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mylan Pharma UK Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Viatris Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when&#xD;
      administered by inhalation in adult asthma patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)</measure>
    <time_frame>0-12 hours after dosing on Day 1</time_frame>
    <description>The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)</measure>
    <time_frame>0-12 hours after dosing on Day 1</time_frame>
    <description>The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1 Trough Value (Assay Sensitivity)</measure>
    <time_frame>Day 1 and Day 29</time_frame>
    <description>Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1 Trough Value (Bioequivalence)</measure>
    <time_frame>Day 1 and Day 29</time_frame>
    <description>Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1128</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>MGR001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MGR001 administered two times per day by 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 administered two times per day by 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 for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)</intervention_name>
    <description>Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
    <arm_group_label>MGR001</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)</intervention_name>
    <description>Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
    <arm_group_label>Advair Diskus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo administered via the CRC749 and Diskus devices</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key inclusion criteria include:&#xD;
&#xD;
          -  Male or female subjects aged ≥18 years. Females may be of either childbearing or&#xD;
             non-childbearing potential&#xD;
&#xD;
          -  Physician diagnosed history of asthma for at least 12 weeks prior to screening&#xD;
&#xD;
          -  pre-bronchodilator FEV1 60-85% at screening and other specified visits&#xD;
&#xD;
          -  Post-bronchodilator reversibility &gt;/=12%&#xD;
&#xD;
          -  Non-smokers and prior smokers with no history of smoking within the past 12 months&#xD;
             prior to screening and a total smoking history of ≤10 pack-years&#xD;
&#xD;
          -  Subjects able to discontinue asthma medications for the duration of the study and be&#xD;
             maintained using albuterol as required&#xD;
&#xD;
          -  Body mass index between 18-40 kg/m2 inclusive&#xD;
&#xD;
        Key exclusion criteria include:&#xD;
&#xD;
          -  Presence or recent history of any other active, severe, progressive, and/or&#xD;
             uncontrolled clinical disease, eg, poorly controlled Type 1 or 2 diabetes, seizure&#xD;
             disorder or epilepsy, cerebrovascular accident, significant cardiac conduction&#xD;
             abnormalities&#xD;
&#xD;
          -  Respiratory conditions other than asthma and allergic rhinitis, including but not&#xD;
             limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive&#xD;
             pulmonary disease, bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary&#xD;
             fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis&#xD;
&#xD;
          -  History of life-threatening asthma, defined as a history of asthma episode(s)&#xD;
             requiring intubation, and/or associated with hypercapnia; respiratory arrest or&#xD;
             hypoxic seizures, asthma related syncopal episode(s)&#xD;
&#xD;
          -  In patient hospitalization (not including ER visits) for an asthma exacerbation within&#xD;
             the past year or during the run in period&#xD;
&#xD;
          -  An asthma exacerbation requiring change in asthma therapy or oral/IV corticosteroids&#xD;
             in the 3 months prior to screening&#xD;
&#xD;
          -  History of seasonally unstable asthma where the season will coincide with the&#xD;
             subject's participation in the study&#xD;
&#xD;
          -  Use of prescription or non-prescription drugs, including beta blockers, tricyclic&#xD;
             antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines,&#xD;
             monoamine oxidase inhibitors, etc&#xD;
&#xD;
          -  Suspected hypersensitivity to the study drugs (including lactose) or severe milk&#xD;
             protein allergy&#xD;
&#xD;
          -  Clinically significant abnormalities in the screening ECG&#xD;
&#xD;
          -  Evidence of alcohol or drug abuse or dependency within 6 months prior to screening&#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>Dik WH Ng, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Mylan Pharma UK Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mylan Investigative Site #1</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #2</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #3</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #4</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #5</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #6</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #7</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #8</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #9</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #10</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #11</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #12</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #13</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #14</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #15</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #16</name>
      <address>
        <city>Napa</city>
        <state>California</state>
        <zip>94558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #17</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #18</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigational Site #27</name>
      <address>
        <city>Rolling Hills Estates</city>
        <state>California</state>
        <zip>90274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #19</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95842</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #20</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #21</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #101</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #22</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #23</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #24</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #25</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #26</name>
      <address>
        <city>Wheat Ridge</city>
        <state>Colorado</state>
        <zip>80033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #28</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #29</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #30</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #31</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #32</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #34</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #33</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #35</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #36</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #37</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #38</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #39</name>
      <address>
        <city>River Forest</city>
        <state>Illinois</state>
        <zip>60305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #40</name>
      <address>
        <city>Shiloh</city>
        <state>Illinois</state>
        <zip>62269</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #41</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #42</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #43</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #44</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #45</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #46</name>
      <address>
        <city>White Marsh</city>
        <state>Maryland</state>
        <zip>21162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #47</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #48</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #49</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #50</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #51</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #52</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #53</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #54</name>
      <address>
        <city>Warrensburg</city>
        <state>Missouri</state>
        <zip>64093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #55</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #56</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #57</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68123-4303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #58</name>
      <address>
        <city>Brick</city>
        <state>New Jersey</state>
        <zip>08724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #59</name>
      <address>
        <city>Ocean City</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #60</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <zip>08558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #61</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #62</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #63</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #64</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #65</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #66</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #67</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #68</name>
      <address>
        <city>Sylvania</city>
        <state>Ohio</state>
        <zip>43560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #69</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #70</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #71</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136-8303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #72</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #73</name>
      <address>
        <city>Lake Oswego</city>
        <state>Oregon</state>
        <zip>97035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #74</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #75</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #76</name>
      <address>
        <city>Jenkintown</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #77</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #78</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #79</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #80</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #81</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #82</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #83</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #84</name>
      <address>
        <city>Boerne</city>
        <state>Texas</state>
        <zip>78006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #85</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #86</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #87</name>
      <address>
        <city>Dickinson</city>
        <state>Texas</state>
        <zip>77539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #88</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #89</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #90</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #91</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #92</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #93</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #94</name>
      <address>
        <city>South Burlington</city>
        <state>Vermont</state>
        <zip>05403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #95</name>
      <address>
        <city>Henrico</city>
        <state>Virginia</state>
        <zip>23233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #96</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #97</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #98</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #99</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mylan Investigative Site #100</name>
      <address>
        <city>Greenfield</city>
        <state>Wisconsin</state>
        <zip>53228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Ng D, Kerwin EM, White MV, Miller SD, Haughie S, Ward JK, Allan R. Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma. J Aerosol Med Pulm Drug Deliv. 2020 Apr;33(2):99-107. doi: 10.1089/jamp.2019.1547. Epub 2019 Oct 31.</citation>
    <PMID>31634023</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>November 13, 2020</results_first_submitted>
  <results_first_submitted_qc>December 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 12, 2021</results_first_posted>
  <disposition_first_submitted>May 25, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>May 25, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 6, 2016</disposition_first_posted>
  <last_update_submitted>February 22, 2022</last_update_submitted>
  <last_update_submitted_qc>February 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>fluticasone</keyword>
  <keyword>salmeterol</keyword>
  <keyword>CRC749</keyword>
  <keyword>Diskus</keyword>
  <keyword>Advair</keyword>
  <keyword>FEV1</keyword>
  <keyword>MGR001</keyword>
  <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>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MGR001</title>
          <description>MGR001 administered two times per day by inhalation throughout the study&#xD;
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
        </group>
        <group group_id="P2">
          <title>Advair Diskus</title>
          <description>Advair Diskus administered two times per day by inhalation throughout the study&#xD;
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study&#xD;
Placebo: Placebo administered via the CRC749 and Diskus devices</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="512"/>
                <participants group_id="P2" count="513"/>
                <participants group_id="P3" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="499"/>
                <participants group_id="P2" count="500"/>
                <participants group_id="P3" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <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="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <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="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized in error (not treated)</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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population included all subjects who were randomized and received at least one dose of double-blind study medication. One subject was randomized in error to the Advair Diskus group but was not treated and so not included in the baseline analysis population</population>
      <group_list>
        <group group_id="B1">
          <title>MGR001</title>
          <description>MGR001 administered two times per day by inhalation throughout the study&#xD;
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
        </group>
        <group group_id="B2">
          <title>Advair Diskus</title>
          <description>Advair Diskus administered two times per day by inhalation throughout the study&#xD;
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study&#xD;
Placebo: Placebo administered via the CRC749 and Diskus devices</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="512"/>
            <count group_id="B2" value="512"/>
            <count group_id="B3" value="103"/>
            <count group_id="B4" value="1127"/>
          </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="42.6" spread="14.08"/>
                    <measurement group_id="B2" value="42.5" spread="14.21"/>
                    <measurement group_id="B3" value="43.5" spread="13.85"/>
                    <measurement group_id="B4" value="42.6" spread="14.11"/>
                  </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="306"/>
                    <measurement group_id="B2" value="309"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="679"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="206"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="448"/>
                  </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="102"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="218"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="410"/>
                    <measurement group_id="B2" value="420"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="909"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="212"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="378"/>
                    <measurement group_id="B2" value="372"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="823"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="67"/>
                  </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="512"/>
                    <measurement group_id="B2" value="512"/>
                    <measurement group_id="B3" value="103"/>
                    <measurement group_id="B4" value="1127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</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="29.38" spread="6.026"/>
                    <measurement group_id="B2" value="29.12" spread="5.886"/>
                    <measurement group_id="B3" value="29.37" spread="5.890"/>
                    <measurement group_id="B4" value="29.26" spread="5.947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)</title>
        <description>The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo</description>
        <time_frame>0-12 hours after dosing on Day 1</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>MGR001</title>
            <description>MGR001 administered two times per day by inhalation throughout the study&#xD;
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Advair Diskus</title>
            <description>Advair Diskus administered two times per day by inhalation throughout the study&#xD;
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study&#xD;
Placebo: Placebo administered via the CRC749 and Diskus devices</description>
          </group>
        </group_list>
        <measure>
          <title>Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)</title>
          <description>The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo</description>
          <population>Full Analysis Set</population>
          <units>L*hr</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="508"/>
                <count group_id="O2" value="510"/>
                <count group_id="O3" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9534" spread="0.1609"/>
                    <measurement group_id="O2" value="3.4964" spread="0.1595"/>
                    <measurement group_id="O3" value="0.8191" spread="0.3477"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>MGR001 (Test) vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Advair Diskus (Reference) vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>In order for the bioequivalence results to be valid, assay sensitivity had to be established.For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)</title>
        <description>The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures</description>
        <time_frame>0-12 hours after dosing on Day 1</time_frame>
        <population>Per Protocol Set</population>
        <group_list>
          <group group_id="O1">
            <title>MGR001</title>
            <description>MGR001 administered two times per day by inhalation throughout the study&#xD;
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Advair Diskus</title>
            <description>Advair Diskus administered two times per day by inhalation throughout the study&#xD;
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study&#xD;
Placebo: Placebo administered via the CRC749 and Diskus devices</description>
          </group>
        </group_list>
        <measure>
          <title>Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)</title>
          <description>The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures</description>
          <population>Per Protocol Set</population>
          <units>L*hr</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="497"/>
                <count group_id="O2" value="494"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9734" spread="0.1704"/>
                    <measurement group_id="O2" value="3.5411" spread="0.1593"/>
                    <measurement group_id="O3" value="0.8400" spread="0.2983"/>
                  </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>Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).</non_inferiority_desc>
            <param_type>Ratio (MGR001/Advair Diskus)</param_type>
            <param_value>1.120</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.016</ci_lower_limit>
            <ci_upper_limit>1.237</ci_upper_limit>
            <estimate_desc>Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for the FEV1 AUEC0-12 clinical endpoint</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FEV1 Trough Value (Assay Sensitivity)</title>
        <description>Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.</description>
        <time_frame>Day 1 and Day 29</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>MGR001</title>
            <description>MGR001 administered two times per day by inhalation throughout the study&#xD;
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Advair Diskus</title>
            <description>Advair Diskus administered two times per day by inhalation throughout the study&#xD;
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study&#xD;
Placebo: Placebo administered via the CRC749 and Diskus devices</description>
          </group>
        </group_list>
        <measure>
          <title>FEV1 Trough Value (Assay Sensitivity)</title>
          <description>Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.</description>
          <population>Full Analysis Set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="504"/>
                <count group_id="O2" value="505"/>
                <count group_id="O3" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2927" spread="0.0162"/>
                    <measurement group_id="O2" value="0.2720" spread="0.0161"/>
                    <measurement group_id="O3" value="0.0575" spread="0.0353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>MGR001 (Test) vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Advair Diskus (Reference) vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FEV1 Trough Value (Bioequivalence)</title>
        <description>Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]</description>
        <time_frame>Day 1 and Day 29</time_frame>
        <population>Per Protocol Set</population>
        <group_list>
          <group group_id="O1">
            <title>MGR001</title>
            <description>MGR001 administered two times per day by inhalation throughout the study&#xD;
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
          </group>
          <group group_id="O2">
            <title>Advair Diskus</title>
            <description>Advair Diskus administered two times per day by inhalation throughout the study&#xD;
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study&#xD;
Placebo: Placebo administered via the CRC749 and Diskus devices</description>
          </group>
        </group_list>
        <measure>
          <title>FEV1 Trough Value (Bioequivalence)</title>
          <description>Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]</description>
          <population>Per Protocol Set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="498"/>
                <count group_id="O2" value="497"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2911" spread="0.0163"/>
                    <measurement group_id="O2" value="0.2728" spread="0.0162"/>
                    <measurement group_id="O3" value="0.0574" spread="0.0355"/>
                  </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>Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).</non_inferiority_desc>
            <param_type>Ratio (MGR001/Advair Diskus)</param_type>
            <param_value>1.069</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.938</ci_lower_limit>
            <ci_upper_limit>1.220</ci_upper_limit>
            <estimate_desc>Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for change from baseline in trough FEV1 endpoint on Day 29</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected from the signing of the ICF but are reported from Day 1 to 30 days after the last dose of double-blind study medication.</time_frame>
      <desc>Subjects were routinely queried for AEs using open-ended questions. Spontaneously reported AEs were also recorded. The most frequent AEs occurring in at least 3 subjects across the 3 treatment groups are reported, equating to 0.2% of subjects in the Safety Set.</desc>
      <group_list>
        <group group_id="E1">
          <title>MGR001</title>
          <description>MGR001 administered two times per day by inhalation throughout the study&#xD;
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device</description>
        </group>
        <group group_id="E2">
          <title>Advair Diskus</title>
          <description>Advair Diskus administered two times per day by inhalation throughout the study&#xD;
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study&#xD;
Placebo: Placebo administered via the CRC749 and Diskus devices</description>
        </group>
      </group_list>
      <serious_events>
        <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="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.2</frequency_threshold>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="512"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="512"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="103"/>
              </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 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>
    <point_of_contact>
      <name_or_title>Dik Ng, PhD</name_or_title>
      <organization>Mylan Pharma UK Ltd</organization>
      <phone>+44-7467-941703</phone>
      <email>dik.ng@mylan.co.uk</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/NCT02245672
org study id: MGR001-3001
nct id: NCT02245672
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when
      administered by inhalation in adult asthma patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)
time frame: 0-12 hours after dosing on Day 1
description: The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo
measure: Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)
time frame: 0-12 hours after dosing on Day 1
description: The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures
measure: FEV1 Trough Value (Assay Sensitivity)
time frame: Day 1 and Day 29
description: Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.
measure: FEV1 Trough Value (Bioequivalence)
time frame: Day 1 and Day 29
description: Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of [prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1]
arm group label: MGR001
arm group type: Experimental
description: MGR001 administered two times per day by inhalation throughout the study
arm group label: Advair Diskus
arm group type: Active Comparator
description: Advair Diskus administered two times per day by inhalation throughout the study
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study
intervention type: Drug
intervention name: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
description: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device
arm group label: MGR001
intervention type: Drug
intervention name: Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
description: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device
arm group label: Advair Diskus
intervention type: Drug
intervention name: Placebo
description: Placebo administered via the CRC749 and Diskus devices
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dik WH Ng, PhD
role: Study Director
affiliation: Mylan Pharma UK Ltd.
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country: United States
citation: Ng D, Kerwin EM, White MV, Miller SD, Haughie S, Ward JK, Allan R. Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma. J Aerosol Med Pulm Drug Deliv. 2020 Apr;33(2):99-107. doi: 10.1089/jamp.2019.1547. Epub 2019 Oct 31.
PMID: 31634023
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
mesh term: Salmeterol Xinafoate
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