<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/NCT03015259</url>
  </required_header>
  <id_info>
    <org_study_id>CSP-07-000034</org_study_id>
    <nct_id>NCT03015259</nct_id>
  </id_info>
  <brief_title>Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients</brief_title>
  <official_title>Randomized, Single Blind, Parallel Group, Placebo Controlled, Multidose Study Comparing the Therapeutic Equivalence of a 3M Budesonide/Formoterol Fumarate Inhaler and a Symbicort® Reference Inhaler in Adult Subjects With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kindeva Drug Delivery</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kindeva Drug Delivery</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, placebo-controlled, parallel group design consisting of a 2-week&#xD;
      run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide&#xD;
      80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation&#xD;
      aerosol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pivotal trial that will examine therapeutic equivalence of a new generic fixed-dose&#xD;
      combination product containing Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg and&#xD;
      reference listed drug (RLD) Symbicort® inhalation aerosol in adult patients with chronic but&#xD;
      stable asthma as defined in National Asthma Education and Prevention Program Expert Panel&#xD;
      Report 3 (NAEPP 3) guidelines. To ensure adequate study sensitivity the test and reference&#xD;
      products should both be statistically superior to placebo (p&lt;0.05) with regard to the&#xD;
      bioequivalent study primary endpoints.&#xD;
&#xD;
      A secondary study objective is the safety and tolerability of the test compound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">February 8, 2018</completion_date>
  <primary_completion_date type="Actual">February 8, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)</measure>
    <time_frame>Day 1</time_frame>
    <description>FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit</measure>
    <time_frame>Day 1 - Day 49</time_frame>
    <description>Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Number of participants reporting at least one adverse event (safety population)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1762</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Treatment 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide/Formoterol fumarate dihydrate</intervention_name>
    <description>Experimental: Treatment 1</description>
    <arm_group_label>Treatment 1</arm_group_label>
    <other_name>Generic Budesonide/Formoterol fumarate dihydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symbicort</intervention_name>
    <description>Active Comparator: Treatment 2</description>
    <arm_group_label>Treatment 2</arm_group_label>
    <other_name>Budesonide/Formoterol fumarate dihydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Comparator: Treatment 3</description>
    <arm_group_label>Treatment 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male or female subjects of non-childbearing or of childbearing potential&#xD;
             committed to consistent and correct use of an acceptable method of birth control&#xD;
&#xD;
          -  Diagnosed with asthma, as defined by the National Asthma Education and Prevention&#xD;
             Program (NAEPP),at least 6 months prior to screening&#xD;
&#xD;
          -  Moderate-to-severe asthma with a pre-bronchodilator FEV1 of &gt;45% and &lt;85% of predicted&#xD;
             normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24&#xD;
             hours after the last dose of long-acting β agonist (LABA), at the screening visit and&#xD;
             on the day of treatment&#xD;
&#xD;
          -  &gt;15% and &gt;0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of&#xD;
             albuterol inhalation (pMDI)&#xD;
&#xD;
          -  Patients should be stable on their chronic asthma treatment regimen for at least 4&#xD;
             weeks prior to enrollment&#xD;
&#xD;
          -  Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars,&#xD;
             pipe tobacco) within the past year, and having &lt; 10 pack-years of historical use&#xD;
&#xD;
          -  Able to replace current regularly scheduled short-acting β agonists (SABAs) with&#xD;
             salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of&#xD;
             the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours&#xD;
             prior to lung function assessments on study visits)&#xD;
&#xD;
          -  Willing to discontinue their asthma medications (inhaled corticosteroids and&#xD;
             long-acting β agonists) during the run-in period and for the remainder of the study&#xD;
&#xD;
          -  Willingness to give their written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life-threatening asthma, defined as a history of asthma episodes(s) requiring&#xD;
             intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic&#xD;
             seizures, asthma-related syncopal episodes(s), or hospitalizations within the past&#xD;
             year or during the run-in period&#xD;
&#xD;
          -  Significant respiratory disease other than asthma (chronic obstructive pulmonary&#xD;
             disease (COPD), interstitial lung disease, etc.)&#xD;
&#xD;
          -  Evidence or history of clinically significant disease or abnormality including&#xD;
             congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery&#xD;
             disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or&#xD;
             current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal,&#xD;
             or other diseases that, in the opinion of the investigator, would put the patient at&#xD;
             risk through study participation, or would affect the study analyses if the disease&#xD;
             exacerbated during the study&#xD;
&#xD;
          -  Patients who required systemic corticosteroids (for any reason) within the past 4&#xD;
             weeks&#xD;
&#xD;
          -  Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any&#xD;
             inhaled, intranasal, or systemic corticosteroid therapy&#xD;
&#xD;
          -  Patients currently receiving β-blockers&#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>KINDEVA I DD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Kindeva Drug Delivery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Center of Alabama LLC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consortuim Arizona</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85253</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Little Rock Allergy and Asthma Clinical Research Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Warren W Pleskow MD</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Specialists Medical Group</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Allergy and Asthma Medical Group Inc</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jonathan Corren MD, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Institute For Respiratory Diseases, Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Associates of Southern California, A Medical Group, Inc.</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrated Research Group Inc</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allied Clinical Research LLC</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95842</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Associates of Northern California</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allainz Research Institute Inc</name>
      <address>
        <city>Westminster</city>
        <state>California</state>
        <zip>92683</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western States Clinical Research Inc</name>
      <address>
        <city>Arvada</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Allergy and Asthma Centers PC</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMMUNOe Research Centers</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma and Allergy Associates PC</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Allergy and Asthma Centers PC</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research Inc</name>
      <address>
        <city>Lafayette</city>
        <state>Colorado</state>
        <zip>80026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Center for Clinical Research</name>
      <address>
        <city>Wheat Ridge</city>
        <state>Colorado</state>
        <zip>80033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Sleep Allergy and Lung Institute</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Integrated Medical</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Research of West Florida</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Marcus Research Clinic Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prestige Clinical Research Center Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clintex Research Group, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Research Group LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Applemed Research Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biotech Pharmaceutical Group, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of South Florida Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute Inc</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emerald Coast Research Associates</name>
      <address>
        <city>Panama City</city>
        <state>Florida</state>
        <zip>32405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Dtc</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma and Allergy Center of Chicago Sc</name>
      <address>
        <city>River Forest</city>
        <state>Illinois</state>
        <zip>60305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Analab Clinical Research Inc</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paul Shapero's Private Practice</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Clinical Research Inc</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>212236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda Allergy Asthma and Research Center LLC</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Clinical Research and Consulting LLC</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinity Medical Research LLC</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Medical Research Associates Inc</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute, Inc.</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of the Ozarks INC</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of the Ozarks Inc</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Clinical Research LLC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Clinical Research Center LLC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montana Medical Research</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Clinical Research LLC</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Asthma and Allergy Center PC</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consortium Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allied Clinical Research LLC</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean Allergy &amp; Respiratory Research Center</name>
      <address>
        <city>Brick</city>
        <state>New Jersey</state>
        <zip>08724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Research Center LLC</name>
      <address>
        <city>Ocean Township</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princeton Center For Clinical Research</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <zip>08558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Partners of Western North Carolina</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapha Institute for Clinical Research</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Clinical Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empirical Medical Research</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bernstein Clinical Research Center Inc</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Center For Clinical Research</name>
      <address>
        <city>Sylvania</city>
        <state>Ohio</state>
        <zip>43560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Institute of Clinical Research</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>93617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OK Clinical Research, LLC</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Institute of Allergy and Asthma Clinical Research LLC</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santiago Reyes, MD</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vital Prospects Clinical Research Institute PC</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Research Group</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Southern Oregon PC</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Associates Research Center LLC</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Center LLC</name>
      <address>
        <city>Jenkintown</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montgomery Medical Inc</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma &amp; Allergy Physicians of Rhode Island Clinical Research Institute</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ADAC Research</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Allergy and Asthma Research, LLC</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S. Carolina Pharmaceutical Research</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spartanburg Medical Research</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Phase Research &amp; Development</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AARA Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmaceutical Research &amp; Consulting Inc</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Sky Medical Research</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metroplex Pulmonology &amp; Sleep Center</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Health Research Corporation</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Assurance Research Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Research Center PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvana Research Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma Research Institute</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Resources Inc</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Timber Lane Allergy and Asthma Research LLC</name>
      <address>
        <city>South Burlington</city>
        <state>Vermont</state>
        <zip>05403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Partners LLC</name>
      <address>
        <city>Henrico</city>
        <state>Virginia</state>
        <zip>23233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marycliff Allergy Specialists PS</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma and Sinus Center</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>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>June 13, 2022</results_first_submitted>
  <results_first_submitted_qc>August 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2022</results_first_posted>
  <disposition_first_submitted>December 13, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 13, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 17, 2018</disposition_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bioequivalence</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>Budesonide</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
    <mesh_term>Budesonide, Formoterol Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>October 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03015259/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>March 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03015259/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants (N=1762) were provided a generic placebo pressurized metered dose inhaler (pMDI) device for use during a 2-week Run-in Period for device training. Then, qualified participants (N=1439) were randomly assigned to treatment on a 3:3:1 ratio of generic budesonide/formoterol fumarate dihydrate, Symbicort, or Placebo, respectively.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment 1</title>
          <description>Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Budesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1</description>
        </group>
        <group group_id="P2">
          <title>Treatment 2</title>
          <description>Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Symbicort: Active Comparator: Treatment 2</description>
        </group>
        <group group_id="P3">
          <title>Treatment 3</title>
          <description>Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Placebo: Placebo Comparator: Treatment 3</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="613"/>
                <participants group_id="P2" count="622"/>
                <participants group_id="P3" count="204"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="598"/>
                <participants group_id="P2" count="604"/>
                <participants group_id="P3" count="199"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized participants who received at least 1 dose of study drug during Treatment Period</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment 1</title>
          <description>Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Budesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1</description>
        </group>
        <group group_id="B2">
          <title>Treatment 2</title>
          <description>Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Symbicort: Active Comparator: Treatment 2</description>
        </group>
        <group group_id="B3">
          <title>Treatment 3</title>
          <description>Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Placebo: Placebo Comparator: Treatment 3</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="613"/>
            <count group_id="B2" value="622"/>
            <count group_id="B3" value="204"/>
            <count group_id="B4" value="1439"/>
          </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="46.3" spread="15.02"/>
                    <measurement group_id="B2" value="45.5" spread="14.44"/>
                    <measurement group_id="B3" value="45.5" spread="14.78"/>
                    <measurement group_id="B4" value="45.8" spread="14.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Randomized participants</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="375"/>
                    <measurement group_id="B2" value="392"/>
                    <measurement group_id="B3" value="137"/>
                    <measurement group_id="B4" value="904"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="230"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="535"/>
                  </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="153"/>
                    <measurement group_id="B2" value="151"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="460"/>
                    <measurement group_id="B2" value="471"/>
                    <measurement group_id="B3" value="149"/>
                    <measurement group_id="B4" value="1080"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <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="4"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="262"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="490"/>
                    <measurement group_id="B2" value="495"/>
                    <measurement group_id="B3" value="154"/>
                    <measurement group_id="B4" value="1139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.73" spread="7.667"/>
                    <measurement group_id="B2" value="31.27" spread="8.108"/>
                    <measurement group_id="B3" value="30.93" spread="7.960"/>
                    <measurement group_id="B4" value="30.99" spread="7.900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)</title>
        <description>FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.</description>
        <time_frame>Day 1</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1</title>
            <description>Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Budesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2</title>
            <description>Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Symbicort: Active Comparator: Treatment 2</description>
          </group>
          <group group_id="O3">
            <title>Treatment 3</title>
            <description>Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Placebo: Placebo Comparator: Treatment 3</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)</title>
          <description>FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.</description>
          <population>Per Protocol Population</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="598"/>
                <count group_id="O2" value="604"/>
                <count group_id="O3" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4453" spread="0.1552"/>
                    <measurement group_id="O2" value="4.2790" spread="0.1547"/>
                    <measurement group_id="O3" value="1.6876" spread="0.2782"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Only Treatments 1 and 2 were compared for equivalence. Treatment 3 (placebo) was subtracted from both Treatments 1 and 2, as this primary endpoint was baseline adjusted.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>To show the clinical equivalence, an analysis of covariance model was fit on the participants from the test budesonide/formoterol fumarate and Symbicort groups, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate.</non_inferiority_desc>
            <param_type>Test/Referece LS Mean Ratio</param_type>
            <param_value>1.040</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.958</ci_lower_limit>
            <ci_upper_limit>1.130</ci_upper_limit>
            <estimate_desc>Fieller's formula was applied</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit</title>
        <description>Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].</description>
        <time_frame>Day 1 - Day 49</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1</title>
            <description>Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Budesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2</title>
            <description>Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Symbicort: Active Comparator: Treatment 2</description>
          </group>
          <group group_id="O3">
            <title>Treatment 3</title>
            <description>Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Placebo: Placebo Comparator: Treatment 3</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit</title>
          <description>Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].</description>
          <population>Per Protocol Population</population>
          <units>liter</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="598"/>
                <count group_id="O2" value="604"/>
                <count group_id="O3" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3096" spread="0.0162"/>
                    <measurement group_id="O2" value="0.3077" spread="0.0162"/>
                    <measurement group_id="O3" value="0.1236" spread="0.0285"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Treatments 1 and 2 were baseline adjusted by subtracting Treatment 3 (placebo) from each.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>To show the clinical equivalence, an ANCOVA model was fit with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate.</non_inferiority_desc>
            <param_type>Test/Reference LS Mean Ratio</param_type>
            <param_value>1.004</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.889</ci_lower_limit>
            <ci_upper_limit>1.140</ci_upper_limit>
            <estimate_desc>Fieller's formula was applied</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Number of participants reporting at least one adverse event (safety population)</description>
        <time_frame>6 Weeks</time_frame>
        <population>Safety Population: All enrolled participants who received one dose of a treatment drug. This population was larger than the Per Protocol Population that included only those participants who provided analyzable primary endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1</title>
            <description>Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Budesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2</title>
            <description>Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Symbicort: Active Comparator: Treatment 2</description>
          </group>
          <group group_id="O3">
            <title>Treatment 3</title>
            <description>Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Placebo: Placebo Comparator: Treatment 3</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Number of participants reporting at least one adverse event (safety population)</description>
          <population>Safety Population: All enrolled participants who received one dose of a treatment drug. This population was larger than the Per Protocol Population that included only those participants who provided analyzable primary endpoints.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="613"/>
                <count group_id="O2" value="622"/>
                <count group_id="O3" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Upper respiratory tract infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasopharyngitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Viral upper respiratory tract infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bronchitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cough</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chest discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of means, no formal statistical comparison</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>no statistical significance applied</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 - Day 70</time_frame>
      <desc>Subjects who received at least 1 dose during the Treatment Period (Safety Population).</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment 1</title>
          <description>Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Budesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1</description>
        </group>
        <group group_id="E2">
          <title>Treatment 2</title>
          <description>Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Symbicort: Active Comparator: Treatment 2</description>
        </group>
        <group group_id="E3">
          <title>Treatment 3</title>
          <description>Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period&#xD;
Placebo: Placebo Comparator: Treatment 3</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="613"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="622"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Alcoholic pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>staphylococcal skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Head injurt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>cerebrospinal fluid leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.0)</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="121" subjects_at_risk="613"/>
                <counts group_id="E2" subjects_affected="138" subjects_at_risk="622"/>
                <counts group_id="E3" subjects_affected="71" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>cardia disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>ear and labyrinth disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>eye disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="613"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="622"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>general disorders and administration site conditions</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="613"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="622"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>chest discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>immune system disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="613"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </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" events="12" subjects_affected="12" subjects_at_risk="613"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="622"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>nasopharyngitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="613"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="622"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="613"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="613"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="622"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>infections and infestations</sub_title>
                <counts group_id="E1" events="58" subjects_affected="54" subjects_at_risk="613"/>
                <counts group_id="E2" events="61" subjects_affected="58" subjects_at_risk="622"/>
                <counts group_id="E3" events="21" subjects_affected="20" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>injury, poisoning and procedural complications</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="613"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="622"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>investigations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="613"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="622"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>metabolism and nutrition disorders</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="613"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>musculoskeletal and connective tissue disorders</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="613"/>
                <counts group_id="E2" events="15" subjects_affected="10" subjects_at_risk="622"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>nervous system disorders</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="613"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="622"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="613"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="622"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>pregnancy, puerperium, and perinatal conditions</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>psychiatric disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>renal and urinary disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>asthma</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="613"/>
                <counts group_id="E2" events="28" subjects_affected="24" subjects_at_risk="622"/>
                <counts group_id="E3" events="48" subjects_affected="39" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="613"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="622"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="204"/>
              </event>
              <event>
                <sub_title>respiratory, thoracic and mediastinal disorders</sub_title>
                <counts group_id="E1" events="40" subjects_affected="35" subjects_at_risk="613"/>
                <counts group_id="E2" events="56" subjects_affected="48" subjects_at_risk="622"/>
                <counts group_id="E3" events="64" subjects_affected="48" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>skin and subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="613"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="622"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="204"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>vascular disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="613"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="622"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="204"/>
              </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>
    <limitations_and_caveats>There were no limitations to the trial protocol, no early termination or technical problems.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lester Harrison, PhD</name_or_title>
      <organization>KINDEVA DRUG DELIVERY</organization>
      <phone>6122714814</phone>
      <email>lester.harrison@kindevadd.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/NCT03015259
org study id: CSP-07-000034
nct id: NCT03015259
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week
      run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide
      80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation
      aerosol.
This is a pivotal trial that will examine therapeutic equivalence of a new generic fixed-dose
      combination product containing Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg and
      reference listed drug (RLD) Symbicort® inhalation aerosol in adult patients with chronic but
      stable asthma as defined in National Asthma Education and Prevention Program Expert Panel
      Report 3 (NAEPP 3) guidelines. To ensure adequate study sensitivity the test and reference
      products should both be statistically superior to placebo (p<0.05) with regard to the
      bioequivalent study primary endpoints.

      A secondary study objective is the safety and tolerability of the test compound.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)
time frame: Day 1
description: FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.
measure: Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit
time frame: Day 1 - Day 49
description: Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].
measure: Number of Participants With Adverse Events
time frame: 6 Weeks
description: Number of participants reporting at least one adverse event (safety population)
arm group label: Treatment 1
arm group type: Experimental
description: Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period
arm group label: Treatment 2
arm group type: Active Comparator
description: Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period
arm group label: Treatment 3
arm group type: Placebo Comparator
description: Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period
intervention type: Drug
intervention name: Budesonide/Formoterol fumarate dihydrate
description: Experimental: Treatment 1
arm group label: Treatment 1
other name: Generic Budesonide/Formoterol fumarate dihydrate
intervention type: Drug
intervention name: Symbicort
description: Active Comparator: Treatment 2
arm group label: Treatment 2
other name: Budesonide/Formoterol fumarate dihydrate
intervention type: Drug
intervention name: Placebo
description: Placebo Comparator: Treatment 3
arm group label: Treatment 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: KINDEVA I DD, PhD
role: Study Chair
affiliation: Kindeva Drug Delivery
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country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Budesonide
mesh term: Formoterol Fumarate
mesh term: Budesonide, Formoterol Fumarate Drug Combination
sharing ipd: No
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limitations and caveats: There were no limitations to the trial protocol, no early termination or technical problems.
point of contact: 