<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/NCT03769090</url>
  </required_header>
  <id_info>
    <org_study_id>AV003</org_study_id>
    <nct_id>NCT03769090</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma</brief_title>
  <acronym>MANDALA</acronym>
  <official_title>A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bond Avillion 2 Development LP</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bond Avillion 2 Development LP</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, multicenter, parallel-group, variable-length study to&#xD;
      compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma&#xD;
      exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">February 7, 2022</completion_date>
  <primary_completion_date type="Actual">August 19, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With a Severe Asthma Exacerbation Event</measure>
    <time_frame>From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.</time_frame>
    <description>Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (&lt;24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Annualized Severe Exacerbation Rate</measure>
    <time_frame>From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.</time_frame>
    <description>The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Annualized Dose of Systemic Corticosteroid (SCS)</measure>
    <time_frame>From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.</time_frame>
    <description>This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24</measure>
    <time_frame>From baseline to Week 24</time_frame>
    <description>The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24</measure>
    <time_frame>From baseline to 24 weeks</time_frame>
    <description>The AQLQ+12 consists of 32 questions in 4 domains and is assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3132</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>BDA MDI (PT027) 160/180 μg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Budesonide/albuterol sulfate, BDA MDI, PT027 high dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BDA MDI (PT027) 80/180 μg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Budesonide/albuterol sulfate, BDA MDI, PT027 low dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AS MDI (PT007) 180 µg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Albuterol sulfate MDI, PT007</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg</intervention_name>
    <description>Budesonide/albuterol sulfate combination inhalation aerosol</description>
    <arm_group_label>BDA MDI (PT027) 160/180 μg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg</intervention_name>
    <description>Budesonide/albuterol sulfate combination inhalation aerosol</description>
    <arm_group_label>BDA MDI (PT027) 80/180 μg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albuterol sulfate metered-dose inhaler 180 μg</intervention_name>
    <description>Albuterol sulfate inhalation aerosol</description>
    <arm_group_label>AS MDI (PT007) 180 µg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female or male aged ≥4 years at the time of informed consent&#xD;
&#xD;
          2. Physician diagnosis of asthma documented for at least 1 year&#xD;
&#xD;
          3. Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with&#xD;
             stable dosing for at least the last 4 weeks before Visit 1:&#xD;
&#xD;
               -  Medium-to-high-dose inhaled corticosteroid (ICS)&#xD;
&#xD;
               -  Medium-to-high-dose ICS and 1 additional maintenance therapy from the following:&#xD;
                  leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists&#xD;
                  (LAMA), or theophylline&#xD;
&#xD;
               -  Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist&#xD;
                  (LABA) with or without one additional maintenance therapy from the following:&#xD;
                  LTRA, LAMA, or theophylline&#xD;
&#xD;
          4. Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to &lt;90% predicted&#xD;
             normal value for adults and adolescents, and ≥60 to &lt;100% predicted normal value for&#xD;
             subjects aged 4 to 11 years after withholding specified medications including&#xD;
             short/rapid-acting β2-adrenoreceptor agonist (SABA)&#xD;
&#xD;
          5. Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for&#xD;
             subjects aged ≥18 years) relative to baseline after administration of sponsor provided&#xD;
             Ventolin via central spirometry. One re-test for reversibility testing is allowed&#xD;
             within the screening period in advance of Visit 2&#xD;
&#xD;
          6. Demonstrate acceptable spirometry performance (i.e., meet American Thoracic&#xD;
             Society/European Respiratory Society acceptability/repeatability criteria)&#xD;
&#xD;
          7. A documented history of at least 1 severe asthma exacerbation within 12 months before&#xD;
             Visit 1&#xD;
&#xD;
          8. Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as&#xD;
             assessed by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic&#xD;
             bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or&#xD;
             bronchopulmonary dysplasia)&#xD;
&#xD;
          2. Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit&#xD;
             1&#xD;
&#xD;
          3. Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)&#xD;
&#xD;
          4. Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab)&#xD;
             or investigational biologic within 3 months or any other prohibited medication&#xD;
&#xD;
          5. Current smokers, former smokers with &gt;10 pack-years history, or former smokers who&#xD;
             stopped smoking &lt;6 months before Visit 1 (including all forms of tobacco, e-cigarettes&#xD;
             [vaping], and marijuana)&#xD;
&#xD;
          6. Life-threatening asthma defined as any history of significant asthma episode(s)&#xD;
             requiring intubation associated with hypercapnia, respiratory arrest, hypoxic&#xD;
             seizures, or asthma related syncopal episode(s) within 5 years of Visit 1&#xD;
&#xD;
          7. Historical or current evidence of a clinically significant disease&#xD;
&#xD;
          8. Cancer not in complete remission for at least 5 years&#xD;
&#xD;
          9. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1&#xD;
&#xD;
         10. History of psychiatric disease, intellectual deficiency, poor motivation, or other&#xD;
             conditions if their magnitude is limiting informed consent validity&#xD;
&#xD;
         11. Significant abuse of alcohol or drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Albers, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Avillion LLP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scottsboro</city>
        <state>Alabama</state>
        <zip>35768</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sheffield</city>
        <state>Alabama</state>
        <zip>35660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tuscumbia</city>
        <state>Alabama</state>
        <zip>35674</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bellflower</city>
        <state>California</state>
        <zip>90706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hawthorne</city>
        <state>California</state>
        <zip>90250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rancho Cucamonga</city>
        <state>California</state>
        <zip>91730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Westminster</city>
        <state>California</state>
        <zip>92683</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cape Coral</city>
        <state>Florida</state>
        <zip>33991</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greenacres City</city>
        <state>Florida</state>
        <zip>33467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Northwood</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Peterborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Romford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shipley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sidcup</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wokingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chipps BE, Albers FC, Reilly L, Johnsson E, Cappelletti C, Papi A. Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged &gt;/=4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study. BMJ Open Respir Res. 2021 Dec;8(1):e001077. doi: 10.1136/bmjresp-2021-001077.</citation>
    <PMID>34887317</PMID>
  </reference>
  <results_reference>
    <citation>Papi A, Chipps BE, Beasley R, Panettieri RA Jr, Israel E, Cooper M, Dunsire L, Jeynes-Ellis A, Johnsson E, Rees R, Cappelletti C, Albers FC. Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022 Jun 2;386(22):2071-2083. doi: 10.1056/NEJMoa2203163. Epub 2022 May 15.</citation>
    <PMID>35569035</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>July 29, 2022</results_first_submitted>
  <results_first_submitted_qc>September 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2022</results_first_posted>
  <last_update_submitted>September 1, 2022</last_update_submitted>
  <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
    <mesh_term>Albuterol</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>April 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03769090/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>July 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03769090/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The first subject enrolled on 13 December 2018 and the last subject completed the study on 07 February 2022. Subjects were enrolled at 347 study centers worldwide (Argentina, Canada, Czechia, Germany, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom and the United States).</recruitment_details>
      <pre_assignment_details>The randomized treatment phase started after a 2 to 4 week screening period during which participants used sponsor provided Ventolin HFA (albuterol sulfate) as needed. In addition to the 3,132 participants randomized, 2,488 participants were screened but did not participate, of which 2,456 were ineligible (98.7%). The next most frequent reason was withdrawal by the participant, with 18 meeting this criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>BDA MDI (PT027) 160/180 μg</title>
          <description>Budesonide/albuterol sulfate, BDA MDI, PT027 high dose&#xD;
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol</description>
        </group>
        <group group_id="P2">
          <title>BDA MDI (PT027) 80/180 μg</title>
          <description>Budesonide/albuterol sulfate, BDA MDI, PT027 low dose&#xD;
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol</description>
        </group>
        <group group_id="P3">
          <title>AS MDI (PT007) 180 µg</title>
          <description>Albuterol sulfate MDI, PT007&#xD;
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1016"/>
                <participants group_id="P2" count="1057"/>
                <participants group_id="P3" count="1059"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="915"/>
                <participants group_id="P2" count="933"/>
                <participants group_id="P3" count="916"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="124"/>
                <participants group_id="P3" count="143"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized and did not receive randomized study treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="62"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>A single severe exacerbation event lasting &gt;20 days</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>&gt;= 3 severe exacerbation events within a 3 month period</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>&gt;= 5 total severe exacerbation events</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Condition under investigation worsened</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Of the 3,132 participants randomized, the full analysis set across all ages comprises 3,127 participants as one participant was randomized and did not receive randomized study treatment, and four participants were randomized in error and did not receive randomized study treatment. These five participants have therefore been excluded from the summaries of baseline characteristics, efficacy and safety.</population>
      <group_list>
        <group group_id="B1">
          <title>BDA MDI (PT027) 160/180 μg</title>
          <description>Budesonide/albuterol sulfate, BDA MDI, PT027 high dose&#xD;
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol</description>
        </group>
        <group group_id="B2">
          <title>BDA MDI (PT027) 80/180 μg</title>
          <description>Budesonide/albuterol sulfate, BDA MDI, PT027 low dose&#xD;
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol</description>
        </group>
        <group group_id="B3">
          <title>AS MDI (PT007) 180 µg</title>
          <description>Albuterol sulfate MDI, PT007&#xD;
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol</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="1015"/>
            <count group_id="B2" value="1055"/>
            <count group_id="B3" value="1057"/>
            <count group_id="B4" value="3127"/>
          </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="50.6" spread="15.05"/>
                    <measurement group_id="B2" value="48.5" spread="16.71"/>
                    <measurement group_id="B3" value="49.1" spread="17.22"/>
                    <measurement group_id="B4" value="49.4" spread="16.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Children (&gt;=4 to &lt;12 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adolescents (&gt;=12 to &lt;18 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adults (&gt;=18 to &lt;65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="789"/>
                    <measurement group_id="B2" value="805"/>
                    <measurement group_id="B3" value="784"/>
                    <measurement group_id="B4" value="2378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Elderly (&gt;=65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="192"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="197"/>
                    <measurement group_id="B4" value="566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="647"/>
                    <measurement group_id="B2" value="686"/>
                    <measurement group_id="B3" value="695"/>
                    <measurement group_id="B4" value="2028"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="368"/>
                    <measurement group_id="B2" value="369"/>
                    <measurement group_id="B3" value="362"/>
                    <measurement group_id="B4" value="1099"/>
                  </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="235"/>
                    <measurement group_id="B2" value="261"/>
                    <measurement group_id="B3" value="316"/>
                    <measurement group_id="B4" value="812"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="780"/>
                    <measurement group_id="B2" value="794"/>
                    <measurement group_id="B3" value="741"/>
                    <measurement group_id="B4" value="2315"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="85"/>
                  </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="139"/>
                    <measurement group_id="B2" value="141"/>
                    <measurement group_id="B3" value="137"/>
                    <measurement group_id="B4" value="417"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="820"/>
                    <measurement group_id="B2" value="848"/>
                    <measurement group_id="B3" value="869"/>
                    <measurement group_id="B4" value="2537"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="207"/>
                    <measurement group_id="B4" value="564"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="274"/>
                    <measurement group_id="B2" value="275"/>
                    <measurement group_id="B3" value="290"/>
                    <measurement group_id="B4" value="839"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="128"/>
                    <measurement group_id="B4" value="434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="115"/>
                    <measurement group_id="B4" value="341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serbia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="112"/>
                    <measurement group_id="B4" value="329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="166.8" spread="9.92"/>
                    <measurement group_id="B2" value="165.1" spread="11.45"/>
                    <measurement group_id="B3" value="164.4" spread="11.67"/>
                    <measurement group_id="B4" value="165.4" spread="11.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>Kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.5" spread="16.88"/>
                    <measurement group_id="B2" value="78.2" spread="18.93"/>
                    <measurement group_id="B3" value="78.8" spread="18.47"/>
                    <measurement group_id="B4" value="79.2" spread="18.15"/>
                  </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="28.887" spread="5.4002"/>
                    <measurement group_id="B2" value="28.496" spread="5.5886"/>
                    <measurement group_id="B3" value="28.948" spread="5.6271"/>
                    <measurement group_id="B4" value="28.776" spread="5.5432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Severe Asthma Exacerbation Event</title>
        <description>Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (&lt;24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.</description>
        <time_frame>From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.</time_frame>
        <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</population>
        <group_list>
          <group group_id="O1">
            <title>BDA MDI 160/180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to BDA MDI 160/180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O2">
            <title>AS MDI 180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to AS MDI 180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O3">
            <title>BDA MDI 80/180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to BDA MDI 80/180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O4">
            <title>AS MDI 180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to AS MDI 180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Severe Asthma Exacerbation Event</title>
          <description>Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (&lt;24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.</description>
          <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</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="1013"/>
                <count group_id="O2" value="1014"/>
                <count group_id="O3" value="1054"/>
                <count group_id="O4" value="1056"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207"/>
                    <measurement group_id="O2" value="266"/>
                    <measurement group_id="O3" value="241"/>
                    <measurement group_id="O4" value="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>H0 = null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDA MDI treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.733</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.611</ci_lower_limit>
            <ci_upper_limit>0.879</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>H0 = Null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDI MDI treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.041</p_value>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.835</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.702</ci_lower_limit>
            <ci_upper_limit>0.992</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Severe Exacerbation Rate</title>
        <description>The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable.</description>
        <time_frame>From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.</time_frame>
        <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</population>
        <group_list>
          <group group_id="O1">
            <title>BDA MDI 160/180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to BDA MDI 160/180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O2">
            <title>AS MDI 180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to AS MDI 180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O3">
            <title>BDA MDI 80/180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to BDA MDI 80/180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O4">
            <title>AS MDI 180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to AS MDI 180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Severe Exacerbation Rate</title>
          <description>The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable.</description>
          <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</population>
          <units>Severe exacerbations per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1013"/>
                <count group_id="O2" value="1014"/>
                <count group_id="O3" value="1054"/>
                <count group_id="O4" value="1056"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" lower_limit="0.34" upper_limit="0.60"/>
                    <measurement group_id="O2" value="0.59" lower_limit="0.44" upper_limit="0.78"/>
                    <measurement group_id="O3" value="0.49" lower_limit="0.37" upper_limit="0.64"/>
                    <measurement group_id="O4" value="0.61" lower_limit="0.46" upper_limit="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Negative binomial model</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.028</p_value>
            <method>Negative binomial model</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Annualized Dose of Systemic Corticosteroid (SCS)</title>
        <description>This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period.</description>
        <time_frame>From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.</time_frame>
        <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</population>
        <group_list>
          <group group_id="O1">
            <title>BDA MDI 160/180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to BDA MDI 160/180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O2">
            <title>AS MDI 180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to AS MDI 180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O3">
            <title>BDA MDI 80/180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to BDA MDI 80/180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O4">
            <title>AS MDI 180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to AS MDI 180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Annualized Dose of Systemic Corticosteroid (SCS)</title>
          <description>This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period.</description>
          <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</population>
          <units>Milligram(s)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1012"/>
                <count group_id="O2" value="1011"/>
                <count group_id="O3" value="1052"/>
                <count group_id="O4" value="1052"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2" lower_limit="0" upper_limit="3678"/>
                    <measurement group_id="O2" value="129.3" lower_limit="0" upper_limit="18941"/>
                    <measurement group_id="O3" value="95.5" lower_limit="0" upper_limit="4974"/>
                    <measurement group_id="O4" value="127.1" lower_limit="0" upper_limit="18941"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Wilcoxon rank sum</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.06</p_value>
            <method>Wilcoxon rank sum</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24</title>
        <description>The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5.</description>
        <time_frame>From baseline to Week 24</time_frame>
        <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</population>
        <group_list>
          <group group_id="O1">
            <title>BDA MDI 160/180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to BDA MDI 160/180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O2">
            <title>AS MDI 180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to AS MDI 180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O3">
            <title>BDA MDI 80/180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to BDA MDI 80/180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O4">
            <title>AS MDI 180 μg (Full Analysis Set)</title>
            <description>All participants who are randomized to AS MDI 180 μg, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24</title>
          <description>The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5.</description>
          <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</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="1013"/>
                <count group_id="O2" value="1014"/>
                <count group_id="O3" value="1052"/>
                <count group_id="O4" value="1055"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="677"/>
                    <measurement group_id="O2" value="630"/>
                    <measurement group_id="O3" value="681"/>
                    <measurement group_id="O4" value="650"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.033</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.221</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.016</ci_lower_limit>
            <ci_upper_limit>1.467</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.175</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.132</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.946</ci_lower_limit>
            <ci_upper_limit>1.353</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24</title>
        <description>The AQLQ+12 consists of 32 questions in 4 domains and is assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5.</description>
        <time_frame>From baseline to 24 weeks</time_frame>
        <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</population>
        <group_list>
          <group group_id="O1">
            <title>BDA MDI 160/180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to BDA MDI 160/180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O2">
            <title>BDA MDI 80/180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to BDA MDI 80/180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
          <group group_id="O3">
            <title>AS MDI 180 μg (Full Analysis Set; &gt;=12 Years)</title>
            <description>All participants who are randomized to AS MDI 180 μg, are aged &gt;=12 years at randomization, take at least one puff of randomized treatment and have at least one efficacy assessment, excluding participants identified as confirmed duplicates.</description>
          </group>
        </group_list>
        <measure>
          <title>Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24</title>
          <description>The AQLQ+12 consists of 32 questions in 4 domains and is assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5.</description>
          <population>All participants that were randomized, took at least one puff of randomized treatment, and had at least one efficacy assessment, excluding participants confirmed as duplicates (n = 4). As children &lt;12 years of age were not randomized to the BDA MDI 160/180μg dose, comparison was made to the participants &gt;=12 years of age within the AS MDI 180μg arm.</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="994"/>
                <count group_id="O2" value="987"/>
                <count group_id="O3" value="993"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="508"/>
                    <measurement group_id="O2" value="489"/>
                    <measurement group_id="O3" value="461"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.028</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.228</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.022</ci_lower_limit>
            <ci_upper_limit>1.475</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.111</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.925</ci_lower_limit>
            <ci_upper_limit>1.335</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported AEs are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation, which per protocol, was expected to be at least 24 weeks. The mean and median duration of exposure to randomized treatment for the reporting period for all participants was 44 and 48 weeks, respectively.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BDA MDI (PT027) 160/180 μg</title>
          <description>Budesonide/albuterol sulfate, BDA MDI, PT027 high dose&#xD;
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol</description>
        </group>
        <group group_id="E2">
          <title>BDA MDI (PT027) 80/180 μg</title>
          <description>Budesonide/albuterol sulfate, BDA MDI, PT027 low dose&#xD;
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol</description>
        </group>
        <group group_id="E3">
          <title>AS MDI (PT007) 180 µg</title>
          <description>Albuterol sulfate MDI, PT007&#xD;
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.0)</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="4" subjects_at_risk="1015"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1055"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="1015"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="1055"/>
                <counts group_id="E3" subjects_affected="48" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Cirrhosis alcoholic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to arthropod sting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Anaphylatic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="1015"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1055"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1015"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1055"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1015"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1055"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Suspected COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Urinary retention postoperative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute promyelocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Cholesteatoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Rectal adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Cervicobrachial syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Intensive care unit acquired weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Adjustment disorder with depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Mixed anxiety and depressive disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Colpocele</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </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="7" subjects_affected="7" subjects_at_risk="1015"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="1055"/>
                <counts group_id="E3" events="20" subjects_affected="20" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1055"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (24.0)</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="244" subjects_at_risk="1015"/>
                <counts group_id="E2" subjects_affected="253" subjects_at_risk="1055"/>
                <counts group_id="E3" subjects_affected="243" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="95" subjects_affected="76" subjects_at_risk="1015"/>
                <counts group_id="E2" events="68" subjects_affected="61" subjects_at_risk="1055"/>
                <counts group_id="E3" events="67" subjects_affected="54" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="33" subjects_affected="33" subjects_at_risk="1015"/>
                <counts group_id="E2" events="47" subjects_affected="47" subjects_at_risk="1055"/>
                <counts group_id="E3" events="38" subjects_affected="38" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="31" subjects_affected="26" subjects_at_risk="1015"/>
                <counts group_id="E2" events="35" subjects_affected="31" subjects_at_risk="1055"/>
                <counts group_id="E3" events="28" subjects_affected="26" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="1015"/>
                <counts group_id="E2" events="30" subjects_affected="27" subjects_at_risk="1055"/>
                <counts group_id="E3" events="32" subjects_affected="28" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="1015"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="1055"/>
                <counts group_id="E3" events="28" subjects_affected="25" subjects_at_risk="1057"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="23" subjects_affected="21" subjects_at_risk="1015"/>
                <counts group_id="E2" events="22" subjects_affected="20" subjects_at_risk="1055"/>
                <counts group_id="E3" events="16" subjects_affected="14" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="1015"/>
                <counts group_id="E2" events="23" subjects_affected="23" subjects_at_risk="1055"/>
                <counts group_id="E3" events="20" subjects_affected="20" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="71" subjects_affected="44" subjects_at_risk="1015"/>
                <counts group_id="E2" events="77" subjects_affected="50" subjects_at_risk="1055"/>
                <counts group_id="E3" events="76" subjects_affected="49" subjects_at_risk="1057"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="23" subjects_affected="22" subjects_at_risk="1015"/>
                <counts group_id="E2" events="27" subjects_affected="27" subjects_at_risk="1055"/>
                <counts group_id="E3" events="27" subjects_affected="26" subjects_at_risk="1057"/>
              </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>Data or results obtained from this study must not be published without prior approval from the Sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Avillion LLP</organization>
      <phone>+44 (0)203 764 9530</phone>
      <email>avillion@avillionllp.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/NCT03769090
org study id: AV003
nct id: NCT03769090
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to
      compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma
      exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With a Severe Asthma Exacerbation Event
time frame: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
description: Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (<24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.
measure: Annualized Severe Exacerbation Rate
time frame: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
description: The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable.
measure: Total Annualized Dose of Systemic Corticosteroid (SCS)
time frame: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
description: This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period.
measure: Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24
time frame: From baseline to Week 24
description: The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5.
measure: Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24
time frame: From baseline to 24 weeks
description: The AQLQ+12 consists of 32 questions in 4 domains and is assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5.
arm group label: BDA MDI (PT027) 160/180 μg
arm group type: Experimental
description: Budesonide/albuterol sulfate, BDA MDI, PT027 high dose
arm group label: BDA MDI (PT027) 80/180 μg
arm group type: Experimental
description: Budesonide/albuterol sulfate, BDA MDI, PT027 low dose
arm group label: AS MDI (PT007) 180 µg
arm group type: Active Comparator
description: Albuterol sulfate MDI, PT007
intervention type: Combination Product
intervention name: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
description: Budesonide/albuterol sulfate combination inhalation aerosol
arm group label: BDA MDI (PT027) 160/180 μg
intervention type: Combination Product
intervention name: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
description: Budesonide/albuterol sulfate combination inhalation aerosol
arm group label: BDA MDI (PT027) 80/180 μg
intervention type: Drug
intervention name: Albuterol sulfate metered-dose inhaler 180 μg
description: Albuterol sulfate inhalation aerosol
arm group label: AS MDI (PT007) 180 µg
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: No
last name: Frank Albers, MD, PhD
role: Study Director
affiliation: Avillion LLP
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country: Argentina
country: Canada
country: Czechia
country: Germany
country: Serbia
country: Slovakia
country: South Africa
country: Spain
country: Ukraine
country: United Kingdom
country: United States
citation: Chipps BE, Albers FC, Reilly L, Johnsson E, Cappelletti C, Papi A. Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged >/=4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study. BMJ Open Respir Res. 2021 Dec;8(1):e001077. doi: 10.1136/bmjresp-2021-001077.
PMID: 34887317
citation: Papi A, Chipps BE, Beasley R, Panettieri RA Jr, Israel E, Cooper M, Dunsire L, Jeynes-Ellis A, Johnsson E, Rees R, Cappelletti C, Albers FC. Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022 Jun 2;386(22):2071-2083. doi: 10.1056/NEJMoa2203163. Epub 2022 May 15.
PMID: 35569035
responsible party type: Sponsor
mesh term: Asthma
mesh term: Budesonide
mesh term: Albuterol
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 