<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/NCT03756883</url>
  </required_header>
  <id_info>
    <org_study_id>71736001</org_study_id>
    <nct_id>NCT03756883</nct_id>
  </id_info>
  <brief_title>Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma</brief_title>
  <official_title>A Randomized, Multiple-Dose, Blinded, Placebo-Controlled, Parallel-Design, Multiple-Center, Clinical Study to Evaluate the Therapeutic Equivalence of Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg to ADVAIR DISKUS® 100/50 (Fluticasone Propionate/Salmeterol) Inhalation Powder, in Subjects With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Actavis Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teva Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Actavis Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center&#xD;
      bioequivalence study with pharmacodynamic endpoints&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">November 10, 2019</completion_date>
  <primary_completion_date type="Actual">October 26, 2019</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>Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment</measure>
    <time_frame>12 hours</time_frame>
    <description>Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment.</measure>
    <time_frame>28 days</time_frame>
    <description>Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Area Under the Serial FEV1-time Curve</measure>
    <time_frame>12 hours</time_frame>
    <description>Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted area under the serial FEV1-time curve</description>
  </other_outcome>
  <other_outcome>
    <measure>Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment</measure>
    <time_frame>28 days</time_frame>
    <description>Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">999</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone Propionate and Salmeterol Inhalation Powder</intervention_name>
    <description>100/50 mcg per actuation</description>
    <arm_group_label>Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone Propionate and Salmeterol Inhalation Powder</intervention_name>
    <description>100/50 mcg per actuation</description>
    <arm_group_label>Reference</arm_group_label>
    <other_name>ADVAIR DISKUS®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Inhalation Powder</intervention_name>
    <description>No active content</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or non-pregnant, non-lactating female, ≥ 12 years and ≤ 75 years of age.&#xD;
&#xD;
          2. Signed informed consent form that meets all criteria of current Food and Drug&#xD;
             Administration (FDA) regulations. For subjects who are considered minors in the state&#xD;
             the study is being conducted (&lt; 18 years in most states), the parent or legal guardian&#xD;
             should sign the consent form and the child will be required to sign a subject &quot;assent&quot;&#xD;
             form.&#xD;
&#xD;
          3. Body mass index (BMI) between 18 kg/m2 and 39 kg/m2, inclusive, for subjects &gt; 18&#xD;
             years old. For subjects 12 to 18 years old, BMI between 15 kg/m2 and 35 kg/m2,&#xD;
             inclusive.&#xD;
&#xD;
          4. Female subjects who are of non-childbearing potential must meet one of the following&#xD;
             criteria:&#xD;
&#xD;
               -  surgically sterile (e.g., bilateral oophorectomy, tubal ligation, hysterectomy or&#xD;
                  permanent sterilization procedures), with the procedure performed at least 3&#xD;
                  months before initial dosing&#xD;
&#xD;
               -  naturally postmenopausal (no menses) for at least 1 year before initial dosing&#xD;
                  and/or has a documented FSH level ≥ 40 mIU/mL at screening&#xD;
&#xD;
               -  pre-menarchal&#xD;
&#xD;
          5. Females of childbearing potential must not be pregnant or lactating at Screening or&#xD;
             Randomization as confirmed by a negative serum pregnancy test with a sensitivity of 25&#xD;
             mIU/mL of human chorionic gonadotropin at Screening, and a negative urine pregnancy&#xD;
             test with a sensitivity of less than 50 mIU/mL at all other visits. The subject may&#xD;
             enter the placebo run-in period prior to receipt of test results at Screening, if not&#xD;
             yet received from the clinical laboratory, but should be evaluated by the Investigator&#xD;
             for continued participation once test results are received.&#xD;
&#xD;
             Women of childbearing potential must agree to the use of a reliable method of&#xD;
             contraception (e.g., total abstinence, intrauterine device, a double-barrier method,&#xD;
             oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout&#xD;
             the study. A sterile sexual partner is not considered an adequate form of birth&#xD;
             control. Subjects on hormonal contraceptives must have been on the same hormonal&#xD;
             contraceptive for at least one month before the Screening and continue throughout the&#xD;
             duration of the study.&#xD;
&#xD;
          6. Diagnosis of asthma (based on National Asthma Education and Prevention Program [NAEPP]&#xD;
             guidelines) at least 12 weeks before Screening.&#xD;
&#xD;
          7. Pre-bronchodilator FEV1 ≥ 40% and ≤ 85% of predicted at Screening and Randomization.&#xD;
&#xD;
          8. Airway reversibility ≥ 15% of FEV1 within 30 minutes after receiving 4 puffs of&#xD;
             albuterol inhalation (360 mcg, pressurized metered-dose inhaler) at Screening.&#xD;
&#xD;
          9. Able to discontinue use of their asthma medications during the run-in period and for&#xD;
             the remainder of the study.&#xD;
&#xD;
         10. Able to replace current short-acting beta-agonists [SABAs] with the study supplied&#xD;
             salbutamol/albuterol rescue inhaler for use as needed for the duration of the study.&#xD;
             Subjects must be able to withhold all SABAs for at least 6 hours before lung function&#xD;
             assessments on study visits.&#xD;
&#xD;
         11. Able to continue on stable regimen of theophylline for the duration of the study and&#xD;
             able to withhold theophylline as judged by the Investigator for the required time&#xD;
             intervals before study visits. See Section 10.2.4 for required washouts.&#xD;
&#xD;
         12. Able to discontinue oral corticosteroids, parenteral corticosteroids and oral SABAs&#xD;
             for the time intervals before study visits as specified in Section 10.2.4.&#xD;
&#xD;
         13. Able to perform valid and reproducible pulmonary function tests as per ATS American&#xD;
             Thoracic Society including no evidence of spirometry effort-induced&#xD;
             bronchoconstriction.&#xD;
&#xD;
         14. Currently non-smoking (including vapor cigarettes), no use of any tobacco products&#xD;
             within 1 year prior to Screening and has ≤ 10 pack-years smoking of historical use&#xD;
             (i.e., one pack per day for 10 years).&#xD;
&#xD;
         15. Ability to use the inhalation products correctly.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Life-threatening asthma, defined as a history of asthma episode(s) requiring&#xD;
             intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic&#xD;
             seizures, asthma related syncopal episode(s), or asthma-related hospitalizations&#xD;
             within one year before Screening or during the run-in period.&#xD;
&#xD;
          2. Allergy or significant history of hypersensitivity, idiosyncratic reactions, or&#xD;
             intolerance to any sympathomimetic drug (e.g., salmeterol or albuterol), or any&#xD;
             inhaled, intranasal, or systemic corticosteroid therapy, or milk proteins.&#xD;
&#xD;
          3. History of cystic fibrosis, bronchiectasis, or co-morbid respiratory or sinus&#xD;
             diseases, including chronic obstructive pulmonary disease, chronic bronchitis,&#xD;
             emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary&#xD;
             hypertension that, in the opinion of the Investigator, would compromise subject safety&#xD;
             or interfere with the evaluations.&#xD;
&#xD;
          4. Evidence of viral or bacterial upper or lower respiratory tract infections (e.g.,&#xD;
             pneumonia, viral bronchitis, sinobronchitis, etc.), sinus infection, or middle ear&#xD;
             infection within four weeks before Screening or during the run-in period.&#xD;
&#xD;
          5. Current evidence or history of cardiovascular disorders, including uncontrolled&#xD;
             hypertension, uncontrolled coronary artery disease, known aortic or cerebral aneurysm,&#xD;
             myocardial infarction or stroke, and/or current coronary insufficiency that, in the&#xD;
             opinion of the Investigator, would compromise subject safety or interfere with the&#xD;
             evaluations.&#xD;
&#xD;
          6. Cardiac arrhythmia or 12-lead ECG abnormalities that, in the opinion of the&#xD;
             Investigator, would compromise subject safety or interfere with the evaluations; or a&#xD;
             QTc &gt; 440 ms for males and &gt; 460 ms for females using Fredericia formula.&#xD;
&#xD;
          7. Subjects receiving or who may require during the study non-potassium sparing diuretics&#xD;
             or medications with the potential to affect the course of asthma or to interact with&#xD;
             sympathomimetic amines within 30 days before Screening. Examples include but not&#xD;
             limited to beta blockers, oral decongestants, benzodiazepines, digitalis,&#xD;
             phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors.&#xD;
&#xD;
          8. History of posterior subcapsular cataracts or glaucoma that, in the opinion of the&#xD;
             Investigator, would compromise subject safety.&#xD;
&#xD;
          9. Any clinically significant finding on physical exam or clinical labs that, in the&#xD;
             opinion of the Investigator, would compromise subject's safety or data integrity.&#xD;
&#xD;
         10. History or current evidence of significant renal, hepatic, cardiovascular (including&#xD;
             ECG with evidence of ischemic heart disease, congestive heart failure, and cardiac&#xD;
             dysrhythmia), neurologic, hematologic, endocrine, psychiatric dysfunction, or any&#xD;
             other significant medical illness or disorder in the opinion of the Investigator,&#xD;
             would compromise subject safety or interfere with the evaluations.&#xD;
&#xD;
         11. History of convulsive disorders.&#xD;
&#xD;
         12. History of hyperthyroidism.&#xD;
&#xD;
         13. History of uncontrolled diabetes.&#xD;
&#xD;
         14. History of paradoxical bronchospasm.&#xD;
&#xD;
         15. Use of inhaled SABAs within 6 hours before Screening or use of rescue medication&#xD;
             within 6 hours before Randomization.&#xD;
&#xD;
         16. Use of oral SABAs within 12 hours before Screening.&#xD;
&#xD;
         17. Use of oral or parenteral corticosteroids within one month before Screening.&#xD;
&#xD;
         18. Use of muscarinic beta2-agonists (MABAs), ipratropium bromide, or ipratropium bromide&#xD;
             with albuterol within 24 hours before Screening.&#xD;
&#xD;
         19. Use of cromolyn sodium within 24 hours before Screening.&#xD;
&#xD;
         20. Use of antihistamines (other than cetirizine, desloratadine, or diphenhydramine),&#xD;
             including fexofenadine and loratadine, within 48 hours before Screening or&#xD;
             Randomization.&#xD;
&#xD;
         21. Use of cetirizine within 36 hours before Screening or Randomization.&#xD;
&#xD;
         22. Use of desloratadine within 96 hours before Screening or Randomization.&#xD;
&#xD;
         23. Use of diphenhydramine within 24 hours before Screening or Randomization.&#xD;
&#xD;
         24. Use of inhaled long-acting beta2-agonists (LABAs) (e.g., salmeterol, formoterol) or&#xD;
             combination products containing bronchodilators (e.g., Symbicort) within 24 hours&#xD;
             before Screening.&#xD;
&#xD;
         25. Use of tiotropium within one week before Screening.&#xD;
&#xD;
         26. Exercise within 6 hours before Screening.&#xD;
&#xD;
         27. Use of leukotriene modifiers within 24 hours before Screening.&#xD;
&#xD;
         28. Any surgery within 6 months before Screening that, in the opinion of the Investigator,&#xD;
             would compromise subject safety or integrity of the study data.&#xD;
&#xD;
         29. Biological treatment for asthma, approved or investigational 6 months before Screening&#xD;
             and throughout the study.&#xD;
&#xD;
         30. Receipt of any drug as part of a research study within 30 days before Screening.&#xD;
&#xD;
         31. Positive test results for drugs of abuse, alcohol or cotinine at Screening. Exceptions&#xD;
             will be permitted for positive screens for opiates or stimulants provided there is a&#xD;
             documented prescription for the patient with supporting medical history and diagnosis.&#xD;
&#xD;
         32. Employees of the Investigator or research center or their immediate family members.&#xD;
&#xD;
         33. Previous participation in this study.&#xD;
&#xD;
         34. Inability to understand the requirements of the study and the relative information and&#xD;
             are unable or not willing to comply with the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Study Site 101</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>July 19, 2021</results_first_submitted>
  <results_first_submitted_qc>August 31, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2021</results_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2021</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>No</sharing_ipd>
    <ipd_description>No participant data will be shared.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03756883/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03756883/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The protocol included a minimum 14-day washout of all pre-study medication prior to assignment in the randomized treatment phase of the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test</title>
          <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
        <group group_id="P2">
          <title>Reference</title>
          <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo Inhalation Powder: No active content&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="485"/>
                <participants group_id="P2" count="413"/>
                <participants group_id="P3" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="472"/>
                <participants group_id="P2" count="402"/>
                <participants group_id="P3" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </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="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</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>Significant Worsening of Condition requiring Therapy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reasons</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population</population>
      <group_list>
        <group group_id="B1">
          <title>Test</title>
          <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
        <group group_id="B2">
          <title>Reference</title>
          <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo Inhalation Powder: No active content&#xD;
Dose: 1 inhalation twice daily</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="485"/>
            <count group_id="B2" value="413"/>
            <count group_id="B3" value="101"/>
            <count group_id="B4" value="999"/>
          </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="43.8" spread="16.01"/>
                    <measurement group_id="B2" value="45.2" spread="16.87"/>
                    <measurement group_id="B3" value="48.1" spread="16.91"/>
                    <measurement group_id="B4" value="45.7" spread="16.60"/>
                  </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="305"/>
                    <measurement group_id="B2" value="251"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="616"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                    <measurement group_id="B2" value="162"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="383"/>
                  </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="191"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="386"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="294"/>
                    <measurement group_id="B2" value="255"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="613"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <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="79"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="395"/>
                    <measurement group_id="B2" value="331"/>
                    <measurement group_id="B3" value="84"/>
                    <measurement group_id="B4" value="810"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </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>Asthma History (years)</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="15.87"/>
                    <measurement group_id="B2" value="30.4" spread="16.50"/>
                    <measurement group_id="B3" value="32.6" spread="17.09"/>
                    <measurement group_id="B4" value="30.7" spread="16.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment</title>
        <description>Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.</description>
        <time_frame>12 hours</time_frame>
        <population>Per-Protocol Population that completed the serial assessments on Day 1 of treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
          <group group_id="O2">
            <title>Reference</title>
            <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment</title>
          <description>Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.</description>
          <population>Per-Protocol Population that completed the serial assessments on Day 1 of treatment.</population>
          <units>liters x hours</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="451"/>
                <count group_id="O2" value="379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.03" spread="0.17"/>
                    <measurement group_id="O2" value="3.96" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The 90% Confidence Interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.</non_inferiority_desc>
            <param_type>Test-to-Reference Ratio</param_type>
            <param_value>101.80</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>92.68</ci_lower_limit>
            <ci_upper_limit>111.94</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment.</title>
        <description>Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.</description>
        <time_frame>28 days</time_frame>
        <population>Per-Protocol Population that completed the trial as outlines in SAP.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
          <group group_id="O2">
            <title>Reference</title>
            <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment.</title>
          <description>Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.</description>
          <population>Per-Protocol Population that completed the trial as outlines in SAP.</population>
          <units>Liters</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="432"/>
                <count group_id="O2" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.02"/>
                    <measurement group_id="O2" value="0.34" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The 90% confidence interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.</non_inferiority_desc>
            <param_type>Test-to-Reference Ratio</param_type>
            <param_value>98.09</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>87.10</ci_lower_limit>
            <ci_upper_limit>110.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Area Under the Serial FEV1-time Curve</title>
        <description>Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted area under the serial FEV1-time curve</description>
        <time_frame>12 hours</time_frame>
        <population>mITT Population that completed serial assessments on Day 1 of treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
          <group group_id="O2">
            <title>Reference</title>
            <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo Inhalation Powder: No active content&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Area Under the Serial FEV1-time Curve</title>
          <description>Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted area under the serial FEV1-time curve</description>
          <population>mITT Population that completed serial assessments on Day 1 of treatment.</population>
          <units>liters x hours</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="453"/>
                <count group_id="O2" value="379"/>
                <count group_id="O3" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.02" spread="0.17"/>
                    <measurement group_id="O2" value="3.94" spread="0.18"/>
                    <measurement group_id="O3" value="1.21" spread="0.35"/>
                  </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>Superiority of the test product over the placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <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>Superiority of Reference to placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment</title>
        <description>Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment</description>
        <time_frame>28 days</time_frame>
        <population>mITT Population that completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
          <group group_id="O2">
            <title>Reference</title>
            <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo Inhalation Powder: No active content&#xD;
Dose: 1 inhalation twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment</title>
          <description>Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment</description>
          <population>mITT Population that completed the study.</population>
          <units>Liters</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="462"/>
                <count group_id="O2" value="395"/>
                <count group_id="O3" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.02"/>
                    <measurement group_id="O2" value="0.33" spread="0.02"/>
                    <measurement group_id="O3" value="0.11" spread="0.04"/>
                  </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>Superiority of test over placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <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>Superiority of reference to placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from each subject from the time of ICF signature until the end of study. Total duration for each subject was approximately 3-4 months.</time_frame>
      <desc>AEs were collected at study visits and via the diaries.</desc>
      <group_list>
        <group group_id="E1">
          <title>Test</title>
          <description>Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
        <group group_id="E2">
          <title>Reference</title>
          <description>ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder&#xD;
Fluticasone Propionate and Salmeterol Inhalation Powder: 100/50 mcg per actuation&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo Inhalation Powder: No active content&#xD;
Dose: 1 inhalation twice daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 22.1</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="485"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="413"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="413"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="485"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="413"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="485"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="413"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA Version 22.1</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="3" subjects_at_risk="485"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="413"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <description>Worsening of pre-existing conditions that requires additional therapy (not include rescue albuterol inhaler that was study provided).</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="485"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="413"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="101"/>
              </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>Sponsor reserves the right to review and approve all publications based off data from the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, PD/CE Studies</name_or_title>
      <organization>Teva Pharmaceuticals, USA</organization>
      <phone>1-888-483-8279</phone>
      <email>usmedinfo@tevapharm.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/NCT03756883
org study id: 71736001
nct id: NCT03756883
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center
      bioequivalence study with pharmacodynamic endpoints
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Baseline-adjusted Area Under the Serial FEV1-time Curve Calculated From Time Zero to 12 Hours (AUC0-12h) on Day 1 of Treatment
time frame: 12 hours
description: Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
measure: Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment.
time frame: 28 days
description: Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
measure: Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Area Under the Serial FEV1-time Curve
time frame: 12 hours
description: Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted area under the serial FEV1-time curve
measure: Statistical Superiority of Test and Reference Over Placebo Treatment in Baseline-adjusted Pre-dose FEV1 Measured in the Morning Following 28 Days of Treatment
time frame: 28 days
description: Statistical Superiority of Test and Reference over Placebo Treatment in Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment
arm group label: Test
arm group type: Experimental
description: Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg
arm group label: Reference
arm group type: Active Comparator
description: ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Fluticasone Propionate and Salmeterol Inhalation Powder
description: 100/50 mcg per actuation
arm group label: Test
intervention type: Drug
intervention name: Fluticasone Propionate and Salmeterol Inhalation Powder
description: 100/50 mcg per actuation
arm group label: Reference
other name: ADVAIR DISKUS®
intervention type: Drug
intervention name: Placebo Inhalation Powder
description: No active content
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
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: No
ipd description: No participant data will be shared.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 