<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/NCT01704495</url>
  </required_header>
  <id_info>
    <org_study_id>D3551C00001</org_study_id>
    <secondary_id>2012-001869-33</secondary_id>
    <nct_id>NCT01704495</nct_id>
  </id_info>
  <brief_title>A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.</brief_title>
  <acronym>NIMBUS</acronym>
  <official_title>A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study With an Optional Safety Extension Treatment Period up to 6 Months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients With Uncontrolled Persistent Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <brief_summary>
    <textblock>
      The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of&#xD;
      AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS)&#xD;
      and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase&#xD;
      II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the&#xD;
      Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on&#xD;
      Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists&#xD;
      (LABA), in Patients with Uncontrolled Persistent Asthma&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Severe Asthma Exacerbations During 6 Months</measure>
    <time_frame>From start of treatment up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months</measure>
    <time_frame>From start of treatment up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions</measure>
    <time_frame>From start of treatment up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms</measure>
    <time_frame>From start of treatment up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 2 weeks after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 1 month after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at one month are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 2 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at two months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 3 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at three months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 4 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at four months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at six months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 2 weeks after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 1 month after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at one month are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 2 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at two months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 3 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at three months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 4 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at four months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1</measure>
    <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
    <description>Only patients with both a non-missing value at baseline and visit at six months are included in the analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score</measure>
    <time_frame>Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)</time_frame>
    <description>The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)</measure>
    <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
    <description>The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score</measure>
    <time_frame>Baseline (Day 0), Treatment Period (1,3, and 6 months)</time_frame>
    <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and &gt; 1.5 as marked clinically important differences for any individual domain or for the overall summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score</measure>
    <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
    <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and &gt; 1.5 as marked clinically important differences for any individual domain or for the overall summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms</measure>
    <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Well Controlled Asthma Weeks at Baseline</measure>
    <time_frame>Last 2 weeks before randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Well Controlled Asthma Weeks During Treatment</measure>
    <time_frame>Day 1to end of the 6 months treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline</measure>
    <time_frame>Last 2 weeks before randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Uncontrolled Persistent Asthma Weeks During Treatment</measure>
    <time_frame>Day 1 to end of the 6 months treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plasma Concentration of AZD5069 at Day 7</measure>
    <time_frame>Day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Plasma Concentration of AZD5069 at 1 Month</measure>
    <time_frame>at 1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1147</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>AZD5069 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD5069 oral capsules self-administered twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD5069 15 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD5069 oral capsules self-administered twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD5069 45 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZD5069 oral capsules self-administered twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral capsules self-administered twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD5069</intervention_name>
    <description>AZD5069 oral capsules self-administered twice daily.</description>
    <arm_group_label>AZD5069 15 mg</arm_group_label>
    <arm_group_label>AZD5069 45 mg</arm_group_label>
    <arm_group_label>AZD5069 5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo oral capsules self-administered twice daily.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 years and above. Females of childbearing potential must use a&#xD;
             highly effective contraceptive method plus a condom by their male partner.&#xD;
&#xD;
          -  Diagnosis of asthma for at least 12 months (GINA 2011)&#xD;
&#xD;
          -  Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and&#xD;
             LABA, and with a history of exacerbations during the last year&#xD;
&#xD;
          -  Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment&#xD;
&#xD;
          -  Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant disease or disorder (including any chronic lower&#xD;
             respiratory disease other than asthma) that may put the patient at risk or influence&#xD;
             study results&#xD;
&#xD;
          -  Patients with recurrent, latent, or chronic infections&#xD;
&#xD;
          -  Active tuberculosis or latent tuberculosis without completion of an appropriate course&#xD;
             of treatment or prophylactic treatment&#xD;
&#xD;
          -  Significant lower respiratory tract infection not resolved within 30 days prior to&#xD;
             enrolment&#xD;
&#xD;
          -  Current smoker or smoking history of more than 20 pack years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>150 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bengt Larsson, MEDICAL SCIENCE DIRECTOR</last_name>
    <role>Study Director</role>
    <affiliation>AZ Mondal R&amp;D, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gotse Delchev</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kozloduy</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Petrich</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Razgrad</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ruse</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vidin</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mount Pearl</city>
        <state>Newfoundland and Labrador</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint-Romuald</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quebec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brno</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Karlovy Vary</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kutna Hora</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Melnik</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 5</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 6</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Strakonice</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tabor</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Großhansdorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aszód</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baja</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Balassagyarmat</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cegléd</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gyula</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Komárom</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Makó</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monor</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nyíregyháza</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szombathely</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Százhalombatta</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guadalajara</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mexico</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monterrey</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Białystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gdańsk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Giżycko</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Proszowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Skierniewice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tarnów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Żnin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brasov</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Constanta</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Deva</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Izhevsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vladikavkaz</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bardejov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Komarno</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kosice</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Levice</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poprad</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Spisska Nova Ves</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Surany</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Topolcany</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Trencin</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zvolen</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amanzimtoti</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pretoria</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Umkomaas</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Donetsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporizhzhzya</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporozye</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dundee</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>June 30, 2015</results_first_submitted>
  <results_first_submitted_qc>February 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 1, 2016</results_first_posted>
  <last_update_submitted>February 1, 2016</last_update_submitted>
  <last_update_submitted_qc>February 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Uncontrolled Asthma,</keyword>
  <keyword>Exacerbation,</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>6 months double-blind study with optional safety extension for up to 6 months, were subjects continued on the treatment they were randomized to. First subject enrolled 27 Nov 2012 Last subject last visit 27 Aug 2014 1146 subjects enrolled in tot of which 506 patients were not randomized since they did not fulfilled all the inclusion conditions.</recruitment_details>
      <pre_assignment_details>4 weeks run-in period on background therapy prior to randomization.&#xD;
The discrepancy in the number of enrolled patients compared to the protocol section (n=1147) is because of a patient was in error reported by a monitor as enrolled when the patient was in effect not enrolled.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AZD5069 45 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="P2">
          <title>AZD5069 15 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="P3">
          <title>AZD5069 5 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Placebo oral capsules self-administred twice daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Subjects Randomized</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="156"/>
                <participants group_id="P3" count="160"/>
                <participants group_id="P4" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="141"/>
                <participants group_id="P3" count="144"/>
                <participants group_id="P4" count="145"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other Reason</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinuation criteria met</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Eligibility criteria not fulfilled</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Optional Safety Extension</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116">46 subjects did not enter safety extension</participants>
                <participants group_id="P2" count="121">35 subjects did not enter safety extension</participants>
                <participants group_id="P3" count="114">46 subjects did not enter safety extension</participants>
                <participants group_id="P4" count="116">46 subjects did not enter safety extension</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="88"/>
                <participants group_id="P3" count="83"/>
                <participants group_id="P4" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AZD5069 45 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="B2">
          <title>AZD5069 15 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="B3">
          <title>AZD5069 5 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Placebo oral capsules self-administred twice daily</description>
        </group>
        <group group_id="B5">
          <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="162"/>
            <count group_id="B2" value="156"/>
            <count group_id="B3" value="160"/>
            <count group_id="B4" value="162"/>
            <count group_id="B5" value="640"/>
          </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="51" spread="11.6"/>
                    <measurement group_id="B2" value="52" spread="12.7"/>
                    <measurement group_id="B3" value="53" spread="11.5"/>
                    <measurement group_id="B4" value="54" spread="11.1"/>
                    <measurement group_id="B5" value="52" spread="11.8"/>
                  </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="107"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="104"/>
                    <measurement group_id="B4" value="120"/>
                    <measurement group_id="B5" value="444"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FEV1 pre-bronchodilator</title>
          <units>percentage of predicted normal</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.74" lower_limit="30.11" upper_limit="85.41"/>
                    <measurement group_id="B2" value="66.35" lower_limit="29.92" upper_limit="113.57"/>
                    <measurement group_id="B3" value="65.76" lower_limit="32.57" upper_limit="123.86"/>
                    <measurement group_id="B4" value="61.58" lower_limit="31.13" upper_limit="84.86"/>
                    <measurement group_id="B5" value="64.93" lower_limit="29.92" upper_limit="123.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FEV1 post-bronchodilator</title>
          <units>percentage of predicted normal</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.34" lower_limit="32.33" upper_limit="105.44"/>
                    <measurement group_id="B2" value="77.95" lower_limit="30.38" upper_limit="112.83"/>
                    <measurement group_id="B3" value="76.31" lower_limit="34.88" upper_limit="112.89"/>
                    <measurement group_id="B4" value="72.19" lower_limit="31.26" upper_limit="111.88"/>
                    <measurement group_id="B5" value="75.22" lower_limit="30.38" upper_limit="112.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reversibility</title>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.73" spread="20.617"/>
                    <measurement group_id="B2" value="16.05" spread="15.580"/>
                    <measurement group_id="B3" value="18.41" spread="20.574"/>
                    <measurement group_id="B4" value="18.45" spread="16.342"/>
                    <measurement group_id="B5" value="17.93" spread="18.438"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Severe Asthma Exacerbations During 6 Months</title>
        <time_frame>From start of treatment up to 6 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Severe Asthma Exacerbations During 6 Months</title>
          <population>Full analysis set</population>
          <units>Exacerbations per 6 month</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" lower_limit="0.20" upper_limit="0.50"/>
                    <measurement group_id="O2" value="0.31" lower_limit="0.19" upper_limit="0.49"/>
                    <measurement group_id="O3" value="0.26" lower_limit="0.16" upper_limit="0.42"/>
                    <measurement group_id="O4" value="0.20" lower_limit="0.12" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.119</p_value>
            <p_value_desc>2-sided p-value</p_value_desc>
            <method>Poisson regression</method>
            <method_desc>Correction for overdispersion made by Pearson chi-square</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.56</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>2.49</ci_upper_limit>
            <estimate_desc>AZD5069 45 mg BID vs Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.141</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>Poisson Regression</method>
            <method_desc>Correction for overdispersion made by Pearson chi-square</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.53</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>2.46</ci_upper_limit>
            <estimate_desc>AZD5069 15 mg BID vs Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.397</p_value>
            <p_value_desc>2-sided</p_value_desc>
            <method>Poisson Regression</method>
            <method_desc>Correction for overdispersion made by Pearson chi-square</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.29</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
            <estimate_desc>AZD5069 5 mg BID vs Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months</title>
        <time_frame>From start of treatment up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months</title>
          <units>Exacerbations per 6 month</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" lower_limit="0.01" upper_limit="0.14"/>
                    <measurement group_id="O2" value="0.02" lower_limit="0.00" upper_limit="0.09"/>
                    <measurement group_id="O3" value="0.02" lower_limit="0.02" upper_limit="0.09"/>
                    <measurement group_id="O4" value="0.02" lower_limit="0.01" upper_limit="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions</title>
        <time_frame>From start of treatment up to 6 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions</title>
          <population>Full analysis set</population>
          <units>Days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" lower_limit="0.26" upper_limit="1.12"/>
                    <measurement group_id="O2" value="0.82" lower_limit="0.38" upper_limit="1.77"/>
                    <measurement group_id="O3" value="0.00" lower_limit="0.00" upper_limit="0.01"/>
                    <measurement group_id="O4" value="0.08" lower_limit="0.03" upper_limit="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms</title>
        <time_frame>From start of treatment up to 6 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms</title>
          <population>Full analysis set</population>
          <units>Days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.38" lower_limit="1.33" upper_limit="4.26"/>
                    <measurement group_id="O2" value="2.43" lower_limit="1.33" upper_limit="4.45"/>
                    <measurement group_id="O3" value="2.74" lower_limit="1.42" upper_limit="5.29"/>
                    <measurement group_id="O4" value="1.55" lower_limit="0.80" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 2 weeks after Day 0</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis</description>
          <population>Full analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="149"/>
                <count group_id="O4" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" lower_limit="0.06" upper_limit="0.20"/>
                    <measurement group_id="O2" value="0.07" lower_limit="0.00" upper_limit="0.14"/>
                    <measurement group_id="O3" value="0.09" lower_limit="0.02" upper_limit="0.16"/>
                    <measurement group_id="O4" value="0.12" lower_limit="0.05" upper_limit="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at one month are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 1 month after Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at one month are included in the analysis</description>
          <units>L</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="153"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="146"/>
                <count group_id="O4" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" lower_limit="0.07" upper_limit="0.21"/>
                    <measurement group_id="O2" value="0.08" lower_limit="0.01" upper_limit="0.16"/>
                    <measurement group_id="O3" value="0.09" lower_limit="0.02" upper_limit="0.16"/>
                    <measurement group_id="O4" value="0.09" lower_limit="0.02" upper_limit="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at two months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 2 months after Day 0</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at two months are included in the analysis</description>
          <population>Full analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="143"/>
                <count group_id="O3" value="145"/>
                <count group_id="O4" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" lower_limit="0.06" upper_limit="0.20"/>
                    <measurement group_id="O2" value="0.08" lower_limit="0.01" upper_limit="0.16"/>
                    <measurement group_id="O3" value="0.07" lower_limit="-0.01" upper_limit="0.14"/>
                    <measurement group_id="O4" value="0.12" lower_limit="0.05" upper_limit="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at three months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 3 months after Day 0</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at three months are included in the analysis</description>
          <population>Full analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="142"/>
                <count group_id="O3" value="145"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" lower_limit="0.03" upper_limit="0.18"/>
                    <measurement group_id="O2" value="0.11" lower_limit="0.04" upper_limit="0.18"/>
                    <measurement group_id="O3" value="0.06" lower_limit="-0.02" upper_limit="0.13"/>
                    <measurement group_id="O4" value="0.06" lower_limit="-0.01" upper_limit="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at four months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 4 months after Day 0</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at four months are included in the analysis</description>
          <population>Full analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="142"/>
                <count group_id="O3" value="146"/>
                <count group_id="O4" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" lower_limit="0.09" upper_limit="0.24"/>
                    <measurement group_id="O2" value="0.17" lower_limit="0.09" upper_limit="0.24"/>
                    <measurement group_id="O3" value="0.14" lower_limit="0.06" upper_limit="0.21"/>
                    <measurement group_id="O4" value="0.16" lower_limit="0.08" upper_limit="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at six months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at six months are included in the analysis</description>
          <population>Full Analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="140"/>
                <count group_id="O3" value="145"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" lower_limit="0.06" upper_limit="0.21"/>
                    <measurement group_id="O2" value="0.09" lower_limit="0.01" upper_limit="0.16"/>
                    <measurement group_id="O3" value="0.10" lower_limit="0.03" upper_limit="0.18"/>
                    <measurement group_id="O4" value="0.11" lower_limit="0.04" upper_limit="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 2 weeks after Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis</description>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="143"/>
                <count group_id="O4" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.01" upper_limit="0.11"/>
                    <measurement group_id="O2" value="0.05" lower_limit="-0.01" upper_limit="0.10"/>
                    <measurement group_id="O3" value="0.03" lower_limit="-0.02" upper_limit="0.09"/>
                    <measurement group_id="O4" value="0.03" lower_limit="-0.02" upper_limit="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at one month are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 1 month after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at one month are included in the analysis</description>
          <population>Full Analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="140"/>
                <count group_id="O3" value="141"/>
                <count group_id="O4" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.01" upper_limit="0.12"/>
                    <measurement group_id="O2" value="0.05" lower_limit="0.00" upper_limit="0.11"/>
                    <measurement group_id="O3" value="0.03" lower_limit="-0.03" upper_limit="0.09"/>
                    <measurement group_id="O4" value="0.03" lower_limit="-0.03" upper_limit="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at two months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 2 months after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at two months are included in the analysis</description>
          <population>Full Analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="138"/>
                <count group_id="O3" value="141"/>
                <count group_id="O4" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="-0.02" upper_limit="0.09"/>
                    <measurement group_id="O2" value="0.04" lower_limit="-0.02" upper_limit="0.10"/>
                    <measurement group_id="O3" value="0.01" lower_limit="-0.05" upper_limit="0.07"/>
                    <measurement group_id="O4" value="0.02" lower_limit="-0.04" upper_limit="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at three months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 3 months after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at three months are included in the analysis</description>
          <population>Full Analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="138"/>
                <count group_id="O2" value="136"/>
                <count group_id="O3" value="141"/>
                <count group_id="O4" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" lower_limit="-0.02" upper_limit="0.10"/>
                    <measurement group_id="O2" value="0.04" lower_limit="-0.02" upper_limit="0.10"/>
                    <measurement group_id="O3" value="-0.00" lower_limit="-0.06" upper_limit="0.06"/>
                    <measurement group_id="O4" value="-0.01" lower_limit="-0.07" upper_limit="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at four months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 4 months after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at four months are included in the analysis</description>
          <population>Full Analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="136"/>
                <count group_id="O3" value="141"/>
                <count group_id="O4" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="-0.00" upper_limit="0.12"/>
                    <measurement group_id="O2" value="0.06" lower_limit="0.00" upper_limit="0.13"/>
                    <measurement group_id="O3" value="0.03" lower_limit="-0.03" upper_limit="0.10"/>
                    <measurement group_id="O4" value="0.03" lower_limit="-0.03" upper_limit="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1</title>
        <description>Only patients with both a non-missing value at baseline and visit at six months are included in the analysis</description>
        <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1</title>
          <description>Only patients with both a non-missing value at baseline and visit at six months are included in the analysis</description>
          <population>Full Analysis set</population>
          <units>L</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="136"/>
                <count group_id="O3" value="142"/>
                <count group_id="O4" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.01" upper_limit="0.12"/>
                    <measurement group_id="O2" value="0.02" lower_limit="-0.03" upper_limit="0.08"/>
                    <measurement group_id="O3" value="0.04" lower_limit="-0.02" upper_limit="0.10"/>
                    <measurement group_id="O4" value="-0.01" lower_limit="-0.07" upper_limit="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score</title>
        <description>The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).</description>
        <time_frame>Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score</title>
          <description>The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).</description>
          <population>Full Analysis set</population>
          <units>Units on a scale]</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="149"/>
                <count group_id="O3" value="149"/>
                <count group_id="O4" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.68" lower_limit="-0.83" upper_limit="-0.52"/>
                    <measurement group_id="O2" value="-0.66" lower_limit="-0.82" upper_limit="-0.51"/>
                    <measurement group_id="O3" value="-0.64" lower_limit="-0.80" upper_limit="-0.48"/>
                    <measurement group_id="O4" value="-0.70" lower_limit="-0.86" upper_limit="-0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)</title>
        <description>The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).</description>
        <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)</title>
          <description>The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).</description>
          <population>Full Analysis set</population>
          <units>Participants with improvement</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="134"/>
                <count group_id="O3" value="134"/>
                <count group_id="O4" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="88"/>
                    <measurement group_id="O3" value="73"/>
                    <measurement group_id="O4" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score</title>
        <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and &gt; 1.5 as marked clinically important differences for any individual domain or for the overall summary score.</description>
        <time_frame>Baseline (Day 0), Treatment Period (1,3, and 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score</title>
          <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and &gt; 1.5 as marked clinically important differences for any individual domain or for the overall summary score.</description>
          <units>Overall Score</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="145"/>
                <count group_id="O4" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="0.36" upper_limit="0.65"/>
                    <measurement group_id="O2" value="0.46" lower_limit="0.31" upper_limit="0.61"/>
                    <measurement group_id="O3" value="0.52" lower_limit="0.37" upper_limit="0.67"/>
                    <measurement group_id="O4" value="0.52" lower_limit="0.38" upper_limit="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score</title>
        <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and &gt; 1.5 as marked clinically important differences for any individual domain or for the overall summary score.</description>
        <time_frame>Baseline (Day 0) and 6 months after Day 0</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score</title>
          <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and &gt; 1.5 as marked clinically important differences for any individual domain or for the overall summary score.</description>
          <population>Full Analysis set</population>
          <units>Participants with improvement</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="131"/>
                <count group_id="O4" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="68"/>
                    <measurement group_id="O3" value="69"/>
                    <measurement group_id="O4" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days</title>
          <population>Full Analysis set</population>
          <units>Asthma symptom free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-3.4" upper_limit="2.7"/>
                    <measurement group_id="O2" value="1.6" lower_limit="-1.5" upper_limit="4.6"/>
                    <measurement group_id="O3" value="1.2" lower_limit="-2.0" upper_limit="4.3"/>
                    <measurement group_id="O4" value="1.1" lower_limit="-1.9" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days</title>
          <population>Full Analysis set</population>
          <units>symptom free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="152"/>
                <count group_id="O4" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="-4.3" upper_limit="4.7"/>
                    <measurement group_id="O2" value="2.6" lower_limit="-2.0" upper_limit="7.1"/>
                    <measurement group_id="O3" value="3.4" lower_limit="-1.2" upper_limit="8.1"/>
                    <measurement group_id="O4" value="3.1" lower_limit="-1.4" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days</title>
          <population>Full Analysis set</population>
          <units>symptom free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="149"/>
                <count group_id="O4" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="-3.4" upper_limit="6.3"/>
                    <measurement group_id="O2" value="4.3" lower_limit="-0.6" upper_limit="9.3"/>
                    <measurement group_id="O3" value="3.0" lower_limit="-2.1" upper_limit="8.0"/>
                    <measurement group_id="O4" value="4.0" lower_limit="-0.9" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days</title>
          <population>Full Analysis set</population>
          <units>symptom free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="148"/>
                <count group_id="O4" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="-2.5" upper_limit="7.8"/>
                    <measurement group_id="O2" value="5.6" lower_limit="0.5" upper_limit="10.7"/>
                    <measurement group_id="O3" value="3.9" lower_limit="-1.3" upper_limit="9.2"/>
                    <measurement group_id="O4" value="4.4" lower_limit="-0.7" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days</title>
          <population>Full Analysis set</population>
          <units>asthma control days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-3.9" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.7" lower_limit="-1.1" upper_limit="4.6"/>
                    <measurement group_id="O3" value="1.2" lower_limit="-1.7" upper_limit="4.1"/>
                    <measurement group_id="O4" value="0.9" lower_limit="-1.8" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days</title>
          <population>Full Analysis set</population>
          <units>asthma control days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="151"/>
                <count group_id="O4" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-4.2" upper_limit="4.0"/>
                    <measurement group_id="O2" value="3.5" lower_limit="-0.7" upper_limit="7.7"/>
                    <measurement group_id="O3" value="2.7" lower_limit="-4.2" upper_limit="4.0"/>
                    <measurement group_id="O4" value="2.8" lower_limit="-1.4" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days</title>
          <population>Full Analysis set</population>
          <units>asthma control days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="149"/>
                <count group_id="O4" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="-3.8" upper_limit="5.6"/>
                    <measurement group_id="O2" value="4.7" lower_limit="-0.0" upper_limit="9.4"/>
                    <measurement group_id="O3" value="3.2" lower_limit="-1.6" upper_limit="8.1"/>
                    <measurement group_id="O4" value="2.9" lower_limit="-1.8" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days</title>
          <population>Full Analysis set</population>
          <units>asthma control days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="148"/>
                <count group_id="O4" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="-3.4" upper_limit="6.2"/>
                    <measurement group_id="O2" value="5.7" lower_limit="0.9" upper_limit="10.5"/>
                    <measurement group_id="O3" value="3.9" lower_limit="-1.0" upper_limit="8.8"/>
                    <measurement group_id="O4" value="2.4" lower_limit="-2.3" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days</title>
          <population>Full analysis set</population>
          <units>rescue medication free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="-0.6" upper_limit="8.6"/>
                    <measurement group_id="O2" value="8.3" lower_limit="3.6" upper_limit="13.0"/>
                    <measurement group_id="O3" value="6.8" lower_limit="2.0" upper_limit="11.5"/>
                    <measurement group_id="O4" value="9.5" lower_limit="4.9" upper_limit="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days</title>
          <population>Full Analysis set</population>
          <units>rescue medication free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="4.6" upper_limit="16.8"/>
                    <measurement group_id="O2" value="17.6" lower_limit="11.4" upper_limit="23.8"/>
                    <measurement group_id="O3" value="15.4" lower_limit="9.1" upper_limit="21.8"/>
                    <measurement group_id="O4" value="16.4" lower_limit="10.3" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days</title>
          <units>rescue medication free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="147"/>
                <count group_id="O4" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="5.7" upper_limit="18.9"/>
                    <measurement group_id="O2" value="19.2" lower_limit="12.6" upper_limit="25.9"/>
                    <measurement group_id="O3" value="19.8" lower_limit="13.0" upper_limit="26.6"/>
                    <measurement group_id="O4" value="18.7" lower_limit="12.1" upper_limit="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days</title>
          <population>Full Analysis set</population>
          <units>rescue medication free days</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="147"/>
                <count group_id="O4" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" lower_limit="9.0" upper_limit="22.7"/>
                    <measurement group_id="O2" value="23.1" lower_limit="16.2" upper_limit="29.9"/>
                    <measurement group_id="O3" value="21.2" lower_limit="14.2" upper_limit="28.2"/>
                    <measurement group_id="O4" value="20.0" lower_limit="13.2" upper_limit="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms</title>
          <population>Full analysis set</population>
          <units>night time awakenings</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" lower_limit="-14.6" upper_limit="-5.5"/>
                    <measurement group_id="O2" value="-11.1" lower_limit="-15.7" upper_limit="-6.5"/>
                    <measurement group_id="O3" value="-11.3" lower_limit="-16.0" upper_limit="-6.6"/>
                    <measurement group_id="O4" value="-8.9" lower_limit="-13.4" upper_limit="-4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms</title>
          <population>Full Analysis set</population>
          <units>night time awakenings</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="152"/>
                <count group_id="O4" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.2" lower_limit="-20.7" upper_limit="-9.8"/>
                    <measurement group_id="O2" value="-19.0" lower_limit="-24.5" upper_limit="-13.5"/>
                    <measurement group_id="O3" value="-18.2" lower_limit="-23.8" upper_limit="-12.6"/>
                    <measurement group_id="O4" value="-15.2" lower_limit="-20.7" upper_limit="-9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)</time_frame>
        <population>full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms</title>
          <population>full analysis set</population>
          <units>night time awakenings</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="149"/>
                <count group_id="O4" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.6" lower_limit="-23.2" upper_limit="-11.9"/>
                    <measurement group_id="O2" value="-19.8" lower_limit="-25.5" upper_limit="-14.0"/>
                    <measurement group_id="O3" value="-22.1" lower_limit="-27.9" upper_limit="-16.2"/>
                    <measurement group_id="O4" value="-16.7" lower_limit="-22.4" upper_limit="-11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms</title>
        <time_frame>Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms</title>
          <population>Full analysis set</population>
          <units>night time awakenings</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="148"/>
                <count group_id="O4" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.8" lower_limit="-28.7" upper_limit="-17.0"/>
                    <measurement group_id="O2" value="-25.5" lower_limit="-31.3" upper_limit="-19.6"/>
                    <measurement group_id="O3" value="-25.3" lower_limit="-31.3" upper_limit="-19.3"/>
                    <measurement group_id="O4" value="-21.8" lower_limit="-27.7" upper_limit="-16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Well Controlled Asthma Weeks at Baseline</title>
        <time_frame>Last 2 weeks before randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Well Controlled Asthma Weeks at Baseline</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 Well-controlled asthma weeks Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="152"/>
                    <measurement group_id="O3" value="150"/>
                    <measurement group_id="O4" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Well-controlled asthma weeks Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Well-controlled asthma weeks Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Well Controlled Asthma Weeks During Treatment</title>
        <time_frame>Day 1to end of the 6 months treatment period</time_frame>
        <population>Full Analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Well Controlled Asthma Weeks During Treatment</title>
          <population>Full Analysis set</population>
          <units>well controlled asthma weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="160"/>
                <count group_id="O4" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="4.38"/>
                    <measurement group_id="O2" value="1.9" spread="4.78"/>
                    <measurement group_id="O3" value="2.4" spread="5.38"/>
                    <measurement group_id="O4" value="2.3" spread="5.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline</title>
        <time_frame>Last 2 weeks before randomization</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline</title>
          <population>Full analysis set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="153"/>
                <count group_id="O3" value="156"/>
                <count group_id="O4" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 uncontrolled persistent asthma weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 uncontrolled persistent asthma weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="34"/>
                    <measurement group_id="O4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 uncontrolled persistent asthma weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="96"/>
                    <measurement group_id="O4" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Uncontrolled Persistent Asthma Weeks During Treatment</title>
        <time_frame>Day 1 to end of the 6 months treatment period</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Uncontrolled Persistent Asthma Weeks During Treatment</title>
          <population>Full analysis set</population>
          <units>uncontrolled persistent asthma weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
                <count group_id="O2" value="156"/>
                <count group_id="O3" value="160"/>
                <count group_id="O4" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" spread="10.0"/>
                    <measurement group_id="O2" value="10.7" spread="10.02"/>
                    <measurement group_id="O3" value="10.4" spread="9.84"/>
                    <measurement group_id="O4" value="10.9" spread="9.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Plasma Concentration of AZD5069 at Day 7</title>
        <time_frame>Day 7</time_frame>
        <population>PK analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Plasma Concentration of AZD5069 at Day 7</title>
          <population>PK analysis set</population>
          <units>(nmol/L)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="147"/>
                <count group_id="O3" value="144"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235.0" spread="1525.49"/>
                    <measurement group_id="O2" value="69.9" spread="717.83"/>
                    <measurement group_id="O3" value="25.4" spread="511.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Plasma Concentration of AZD5069 at 1 Month</title>
        <time_frame>at 1 month</time_frame>
        <population>PK analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>AZD5069 45 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O2">
            <title>AZD5069 15 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O3">
            <title>AZD5069 5 mg BID</title>
            <description>AZD5069 oral capsules self-administered twice daily</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo oral capsules self-administred twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Plasma Concentration of AZD5069 at 1 Month</title>
          <population>PK analysis set</population>
          <units>(nmol/L)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="135"/>
                <count group_id="O3" value="139"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.2" spread="11200.64"/>
                    <measurement group_id="O2" value="76.4" spread="788.17"/>
                    <measurement group_id="O3" value="25.8" spread="449.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AZD5069 45 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="E2">
          <title>AZD5069 15 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="E3">
          <title>AZD5069 5 mg BID</title>
          <description>AZD5069 oral capsules self-administered twice daily</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Placebo oral capsules self-administered twice daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>PSEUDOHYPOPARATHYROIDISM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>BARRETTS OESOPHAGUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>HIATUS HERNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>ABDOMINAL HERNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>INGUINAL HERNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS CHRONIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>CHOLELITHIASIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>ABDOMINAL ABSCESS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>HELICOBACTER GASTRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION BACTERIAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>SALMONELLOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>STREPTOCOCCAL SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>ACUTE TONSILLITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>PATELLA FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>RENAL CANCER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>LUNG NEOPLASM MALIGNANT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>UTERINE LEIOMYOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CRITICAL ILLNESS POLYNEUROPATHY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>ISCHAEMIC STROKE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>CALCULUS URETERIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>OVARIAN CYST</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHMA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>ASTHMATIC CRISIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>PERIPHERAL EMBOLISM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <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="86" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="74" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="96" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>GASTROOESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>RHINITIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </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" subjects_affected="2" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>ASTHMA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="153"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="156"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Science Director Bengt Larsson</name_or_title>
      <organization>AstraZeneca</organization>
      <email>ClinicalTrialTransparency@astrazeneca.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/NCT01704495
org study id: D3551C00001
secondary id: 2012-001869-33
nct id: NCT01704495
lead sponsor: 
The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of
      AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS)
      and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase
      II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the
      Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on
      Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists
      (LABA), in Patients with Uncontrolled Persistent Asthma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Rate of Severe Asthma Exacerbations During 6 Months
time frame: From start of treatment up to 6 months
measure: Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months
time frame: From start of treatment up to 6 months
measure: Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
time frame: From start of treatment up to 6 months
measure: Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms
time frame: From start of treatment up to 6 months
measure: Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1
time frame: Baseline (Day 0) and 2 weeks after Day 0
description: Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis
measure: Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1
time frame: Baseline (Day 0) and 1 month after Day 0
description: Only patients with both a non-missing value at baseline and visit at one month are included in the analysis
measure: Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1
time frame: Baseline (Day 0) and 2 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at two months are included in the analysis
measure: Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1
time frame: Baseline (Day 0) and 3 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at three months are included in the analysis
measure: Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1
time frame: Baseline (Day 0) and 4 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at four months are included in the analysis
measure: Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1
time frame: Baseline (Day 0) and 6 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at six months are included in the analysis
measure: Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1
time frame: Baseline (Day 0) and 2 weeks after Day 0
description: Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis
measure: Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1
time frame: Baseline (Day 0) and 1 month after Day 0
description: Only patients with both a non-missing value at baseline and visit at one month are included in the analysis
measure: Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1
time frame: Baseline (Day 0) and 2 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at two months are included in the analysis
measure: Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1
time frame: Baseline (Day 0) and 3 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at three months are included in the analysis
measure: Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1
time frame: Baseline (Day 0) and 4 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at four months are included in the analysis
measure: Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1
time frame: Baseline (Day 0) and 6 months after Day 0
description: Only patients with both a non-missing value at baseline and visit at six months are included in the analysis
measure: Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score
time frame: Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)
description: The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
measure: Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)
time frame: Baseline (Day 0) and 6 months after Day 0
description: The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
measure: Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
time frame: Baseline (Day 0), Treatment Period (1,3, and 6 months)
description: The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
measure: Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
time frame: Baseline (Day 0) and 6 months after Day 0
description: The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
measure: Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
measure: Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
measure: Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
measure: Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)
measure: Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
measure: Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
measure: Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
measure: Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months
measure: Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
measure: Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
measure: Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
measure: Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)
measure: Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms
time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
measure: Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms
time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)
measure: Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms
time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)
measure: Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms
time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)
measure: Number of Participants With Well Controlled Asthma Weeks at Baseline
time frame: Last 2 weeks before randomization
measure: Number of Well Controlled Asthma Weeks During Treatment
time frame: Day 1to end of the 6 months treatment period
measure: Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
time frame: Last 2 weeks before randomization
measure: Number of Uncontrolled Persistent Asthma Weeks During Treatment
time frame: Day 1 to end of the 6 months treatment period
measure: Mean Plasma Concentration of AZD5069 at Day 7
time frame: Day 7
measure: Mean Plasma Concentration of AZD5069 at 1 Month
time frame: at 1 month
arm group label: AZD5069 5 mg
arm group type: Experimental
description: AZD5069 oral capsules self-administered twice daily
arm group label: AZD5069 15 mg
arm group type: Experimental
description: AZD5069 oral capsules self-administered twice daily
arm group label: AZD5069 45 mg
arm group type: Experimental
description: AZD5069 oral capsules self-administered twice daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo oral capsules self-administered twice daily
intervention type: Drug
intervention name: AZD5069
description: AZD5069 oral capsules self-administered twice daily.
arm group label: AZD5069 15 mg
arm group label: AZD5069 45 mg
arm group label: AZD5069 5 mg
intervention type: Drug
intervention name: Placebo
description: Placebo oral capsules self-administered twice daily.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 150 Years
healthy volunteers: No
last name: Bengt Larsson, MEDICAL SCIENCE DIRECTOR
role: Study Director
affiliation: AZ Mondal R&D, Sweden
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country: Bulgaria
country: Canada
country: Czech Republic
country: Germany
country: Hungary
country: Mexico
country: Poland
country: Romania
country: Russian Federation
country: Slovakia
country: South Africa
country: Ukraine
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma
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