<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/NCT01716754</url>
  </required_header>
  <id_info>
    <org_study_id>CQGE031B2201</org_study_id>
    <secondary_id>2012-002298-69</secondary_id>
    <nct_id>NCT01716754</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assessed the effect on asthma control of different dose levels and regimens of&#xD;
      QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2&#xD;
      agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab.&#xD;
      Information from this study was planned to support the design of future studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of QGE031 Participants With Clinically Important Improvement of &lt;= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo</measure>
    <time_frame>Week 16</time_frame>
    <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ACQ-7 Score</measure>
    <time_frame>Baseline, Weeks 4, 8, 12, 16 and 28</time_frame>
    <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1</measure>
    <time_frame>Week 16</time_frame>
    <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score</measure>
    <time_frame>Baseline, Week 16, Week 28</time_frame>
    <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <number_of_arms>14</number_of_arms>
  <enrollment type="Actual">471</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>QGE031 240 mg every 2 weeks (q2w)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QGE031 240 mg q4w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received QGE031 240 mg s.c. q4w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QGE031 180 mg q2w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received QGE031 180 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QGE031 120 mg q2w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received QGE031 120 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QGE031 36 mg q2w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received QGE031 36 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QGE031 12 mg q2w</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received QGE031 12 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omalizumab (as per locally approved dosing table)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to QGE031 240 mg q2w</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to QGE031 240 mg q4w</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to QGE031 180 mg q2w</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received QGE031 180 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to QGE031 120 mg q2w</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received QGE031 120 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to QGE031 36 mg q2w</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received QGE031 36 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to QGE031 12 mg q2w</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received QGE031 12 mg s.c. q2w for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to omalizumab</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QGE031</intervention_name>
    <description>QGE031 was supplied as 120 mg liquid in vial per 1 mL</description>
    <arm_group_label>QGE031 12 mg q2w</arm_group_label>
    <arm_group_label>QGE031 120 mg q2w</arm_group_label>
    <arm_group_label>QGE031 180 mg q2w</arm_group_label>
    <arm_group_label>QGE031 240 mg every 2 weeks (q2w)</arm_group_label>
    <arm_group_label>QGE031 240 mg q4w</arm_group_label>
    <arm_group_label>QGE031 36 mg q2w</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omalizumab</intervention_name>
    <description>Omalizumab was supplied as 150 mg lyophilisate in vial</description>
    <arm_group_label>Omalizumab (as per locally approved dosing table)</arm_group_label>
    <other_name>Xolair</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL</description>
    <arm_group_label>Placebo to QGE031 12 mg q2w</arm_group_label>
    <arm_group_label>Placebo to QGE031 120 mg q2w</arm_group_label>
    <arm_group_label>Placebo to QGE031 180 mg q2w</arm_group_label>
    <arm_group_label>Placebo to QGE031 240 mg q2w</arm_group_label>
    <arm_group_label>Placebo to QGE031 240 mg q4w</arm_group_label>
    <arm_group_label>Placebo to QGE031 36 mg q2w</arm_group_label>
    <arm_group_label>Placebo to omalizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of allergic asthma , uncontrolled on current medication.&#xD;
&#xD;
          -  History of at least 1 asthma exacerbation during the last 1 year&#xD;
&#xD;
          -  Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted&#xD;
             normal value; reversibility following administration of bronchodilator must also be&#xD;
             demonstrated (historical positive reversibility or bronchoprovocation result can be&#xD;
             used).&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Baseline IgE levels or body weight outside the omalizumab dosing table.&#xD;
&#xD;
          -  Use of tobacco products within the previous 6 months (Social occasional smokers may be&#xD;
             included).&#xD;
&#xD;
          -  Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hawaiian Gardens</city>
        <state>California</state>
        <zip>90716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Waldorf</city>
        <state>Maryland</state>
        <zip>20602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Papillion</city>
        <state>Nebraska</state>
        <zip>68046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lincoln</city>
        <state>Rhode Island</state>
        <zip>02865</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29485</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1122AAK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1426ABP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Capital Federal</state>
        <zip>C1430CKE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santa Fe</city>
        <state>Rosario</state>
        <zip>S2000DBS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000AII</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000CXH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B1842DID</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1125ABE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500CBA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500FIK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santa Fe</city>
        <zip>S3000FIL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St-Charles-Borromée</city>
        <state>Quebec</state>
        <zip>J6E 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brno</city>
        <state>Czech Republic</state>
        <zip>639 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Trutnov</city>
        <state>Czech Republic</state>
        <zip>541 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Teplice</city>
        <state>CZE</state>
        <zip>415 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Breclav</city>
        <zip>690 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brno</city>
        <zip>615 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tabor</city>
        <zip>390 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Le Kremlin Bicetre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marseille</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montpellier</city>
        <zip>34059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04275</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Roth</city>
        <zip>91154</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rüdersdorf</city>
        <zip>15562</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <state>GTM</state>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <state>GTM</state>
        <zip>01011</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <zip>01011</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1121</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pecs</city>
        <zip>7635</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Torokbalint</city>
        <zip>2045</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Panjim</city>
        <state>Goa</state>
        <zip>403 002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Karamsad</city>
        <state>Gujrat</state>
        <zip>388325</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dhantoli</city>
        <state>Nagpur</state>
        <zip>12</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rehovot</city>
        <zip>7610001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Messina</city>
        <state>ME</state>
        <zip>98125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Padova</city>
        <state>PD</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pisa</city>
        <state>PI</state>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Reggio Emilia</city>
        <state>RE</state>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Verona</city>
        <state>VR</state>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cheongju-si</city>
        <state>Chungcheongbuk-do</state>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucheon-Si</city>
        <state>Gyeonggi-Do</state>
        <zip>14584</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Korea</state>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gwangju</city>
        <zip>501-757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-755</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>México, D.F.</city>
        <state>Distrito Federal</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Coimbra</city>
        <zip>3041-853</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1169-024</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1749-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Porto</city>
        <zip>4100-180</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucuresti</city>
        <state>District 1</state>
        <zip>10457</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucharest</city>
        <state>District 3</state>
        <zip>030303</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucharest</city>
        <state>District 3</state>
        <zip>030317</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Constanta</city>
        <state>Jud. Constanta</state>
        <zip>900002</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucharest</city>
        <state>ROM</state>
        <zip>12071</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brasov</city>
        <zip>500086</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brasov</city>
        <zip>500112</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brasov</city>
        <zip>500281</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>011461</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>050159</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400139</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400371</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pitesti</city>
        <zip>110114</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barnaul</city>
        <zip>656045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>119992</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>125315</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>127018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>N.Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Penza</city>
        <zip>440026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ryazan</city>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saratov</city>
        <zip>410012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St-Petersburg</city>
        <zip>193312</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bratislava</city>
        <state>Slovak Republic</state>
        <zip>831 03</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nitra</city>
        <state>Slovak Republic</state>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bardejov</city>
        <zip>085 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bratislava</city>
        <zip>826 06</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kosice</city>
        <zip>04001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Prievidza</city>
        <zip>97101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ruzomberok</city>
        <zip>034 26</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Trencin</city>
        <zip>91101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7531</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Durban</city>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aydin</city>
        <zip>09100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fatih / Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34854</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mersin</city>
        <zip>33079</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bradford</city>
        <state>West Yorkshire</state>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>East Yorkshire</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Guatemala</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Panama</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Denmark</country>
    <country>Spain</country>
  </removed_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>January 18, 2017</results_first_submitted>
  <results_first_submitted_qc>January 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2017</results_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>asthma control</keyword>
  <keyword>allergy</keyword>
  <keyword>atopic</keyword>
  <keyword>IgE</keyword>
  <keyword>double-blind</keyword>
  <keyword>placebo</keyword>
  <keyword>omalizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 471 participants were randomized to one of the 14 treatment groups. Of these, 5 participants did not receive study treatment. Therefore, the full analysis set (FAS) and safety set included 466 participants.</recruitment_details>
      <pre_assignment_details>The treatment arms for QGE031 and placebo were pooled into high dose QGE031 (240 mg q2w, 240 mg q4w, 180 mg q2w and 120 q2w), low dose QGE031 (36 mg q2w and 18 mg 2qw) and Placebo Total (all QGE031 placebo and Omalizumab placebo arms).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>QGE031 High Dose</title>
          <description>Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.</description>
        </group>
        <group group_id="P2">
          <title>QGE031 Low Dose</title>
          <description>Participants received QGE031 36 mg q2w or 18 mg q2w.</description>
        </group>
        <group group_id="P3">
          <title>Omalizumab</title>
          <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
        </group>
        <group group_id="P4">
          <title>Placebo Total</title>
          <description>Participants received matching placebo to QGE031 or Omalizumab.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="199"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="135"/>
                <participants group_id="P4" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>FAS</title>
              <participants_list>
                <participants group_id="P1" count="199"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="131"/>
                <participants group_id="P4" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="199"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="131"/>
                <participants group_id="P4" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="188"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="121"/>
                <participants group_id="P4" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with study treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</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="1"/>
              </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="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were based on the FAS.</population>
      <group_list>
        <group group_id="B1">
          <title>QGE031 High Dose</title>
          <description>Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.</description>
        </group>
        <group group_id="B2">
          <title>QGE031 Low Dose</title>
          <description>Participants received QGE031 36 mg q2w or 18 mg q2w.</description>
        </group>
        <group group_id="B3">
          <title>Omalizumab</title>
          <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
        </group>
        <group group_id="B4">
          <title>Placebo Total</title>
          <description>Participants received matching placebo to QGE031 or Omalizumab.</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="199"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="135"/>
            <count group_id="B4" value="97"/>
            <count group_id="B5" value="471"/>
          </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="47.6" spread="13.86"/>
                    <measurement group_id="B2" value="46.0" spread="12.38"/>
                    <measurement group_id="B3" value="46.8" spread="13.35"/>
                    <measurement group_id="B4" value="48.6" spread="12.80"/>
                    <measurement group_id="B5" value="47.4" spread="13.36"/>
                  </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="113"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="63"/>
                    <measurement group_id="B5" value="288"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of QGE031 Participants With Clinically Important Improvement of &lt;= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo</title>
        <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.</description>
        <time_frame>Week 16</time_frame>
        <population>The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>QGE031 240 mg q2w</title>
            <description>Participants received QGE031 240 mg q2w.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to QGE031 240 mg q2w</title>
            <description>Participants received placebo to QGE031 240 mg q2w</description>
          </group>
          <group group_id="O3">
            <title>Omalizumab</title>
            <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of QGE031 Participants With Clinically Important Improvement of &lt;= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo</title>
          <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.</description>
          <population>The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.16"/>
                    <measurement group_id="O2" value="70.21"/>
                    <measurement group_id="O3" value="69.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.576</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>1.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.556</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ACQ-7 Score</title>
        <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.</description>
        <time_frame>Baseline, Weeks 4, 8, 12, 16 and 28</time_frame>
        <population>The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>QGE031 240 mg q2w</title>
            <description>Participants received QGE031 240 mg q2w.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to QGE031 240 mg q2w</title>
            <description>Participants received placebo to QGE031 240 mg q2w</description>
          </group>
          <group group_id="O3">
            <title>Omalizumab</title>
            <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ACQ-7 Score</title>
          <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.</description>
          <population>The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 (n=115,46,122)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="0.709"/>
                    <measurement group_id="O2" value="-0.48" spread="0.834"/>
                    <measurement group_id="O3" value="-0.60" spread="0.705"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (n=110,46,122)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.68" spread="0.678"/>
                    <measurement group_id="O2" value="-0.62" spread="0.735"/>
                    <measurement group_id="O3" value="-0.78" spread="0.687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=110,46,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="0.738"/>
                    <measurement group_id="O2" value="-0.71" spread="0.724"/>
                    <measurement group_id="O3" value="-0.83" spread="0.737"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 (n=114,48,120)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.75" spread="0.817"/>
                    <measurement group_id="O2" value="-0.79" spread="0.733"/>
                    <measurement group_id="O3" value="-0.89" spread="0.734"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n112,47,115)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.62" spread="0.810"/>
                    <measurement group_id="O2" value="-0.63" spread="0.744"/>
                    <measurement group_id="O3" value="-0.59" spread="0.842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1</title>
        <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.</description>
        <time_frame>Week 16</time_frame>
        <population>The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>QGE031 240 mg q2w</title>
            <description>Participants received QGE031 240 mg q2w.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to QGE031 240 mg q2w</title>
            <description>Participants received placebo to QGE031 240 mg q2w</description>
          </group>
          <group group_id="O3">
            <title>Omalizumab</title>
            <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1</title>
          <description>The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - &gt; 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - &lt; 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.</description>
          <population>The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.35"/>
                    <measurement group_id="O2" value="34.04"/>
                    <measurement group_id="O3" value="36.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.483</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>2.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.261</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>2.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score</title>
        <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.</description>
        <time_frame>Baseline, Week 16, Week 28</time_frame>
        <population>The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>QGE031 240 mg q2w</title>
            <description>Participants received QGE031 240 mg q2w.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to QGE031 240 mg q2w</title>
            <description>Participants received placebo to QGE031 240 mg q2w</description>
          </group>
          <group group_id="O3">
            <title>Omalizumab</title>
            <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score</title>
          <description>The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.</description>
          <population>The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16 (n=114,48,122)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.878"/>
                    <measurement group_id="O2" value="0.66" spread="0.624"/>
                    <measurement group_id="O3" value="0.79" spread="0.853"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28 (n=114,47,121)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" spread="0.899"/>
                    <measurement group_id="O2" value="0.63" spread="0.826"/>
                    <measurement group_id="O3" value="0.48" spread="0.871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication</title>
        <description>Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had both baseline and week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>QGE031 240 mg q2w</title>
            <description>Participants received QGE031 240 mg q2w.</description>
          </group>
          <group group_id="O2">
            <title>Placebo to QGE031 240 mg q2w</title>
            <description>Participants received placebo to QGE031 240 mg q2w</description>
          </group>
          <group group_id="O3">
            <title>Omalizumab</title>
            <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication</title>
          <description>Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.</description>
          <population>The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had both baseline and week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.</population>
          <units>Number of puffs</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Morning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.28" spread="0.072"/>
                    <measurement group_id="O2" value="-0.34" spread="0.113"/>
                    <measurement group_id="O3" value="-0.39" spread="0.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.31" spread="0.082"/>
                    <measurement group_id="O2" value="-0.33" spread="0.126"/>
                    <measurement group_id="O3" value="-0.33" spread="0.084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="0.145"/>
                    <measurement group_id="O2" value="-0.64" spread="0.226"/>
                    <measurement group_id="O3" value="-0.73" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Morning</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.604</p_value>
            <method>Repeated measures mixed model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Morning</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.260</p_value>
            <method>Repeated measures mixed model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Evening</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.937</p_value>
            <method>Repeated measures mixed model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Evening</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.880</p_value>
            <method>Repeated measures mixed model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall daily</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.762</p_value>
            <method>Repeated measures mixed model</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Overall daily</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.408</p_value>
            <method>Repeated measures mixed model</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>QGE031 High Dose</title>
          <description>Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.</description>
        </group>
        <group group_id="E2">
          <title>QGE031 Low Dose</title>
          <description>Participants received QGE031 36 mg q2w or 18 mg q2w.</description>
        </group>
        <group group_id="E3">
          <title>Omalizumab</title>
          <description>Participants received omalizumab as per locally approved dosing table q2w or q4w.</description>
        </group>
        <group group_id="E4">
          <title>Placebo Total</title>
          <description>Participants received matching placebo to QGE031 or Omalizumab</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Vaginal laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </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="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="96"/>
              </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="1" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Laryngeal dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="43" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="96"/>
              </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="44" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="131"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="96"/>
              </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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
    </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/NCT01716754
org study id: CQGE031B2201
secondary id: 2012-002298-69
nct id: NCT01716754
lead sponsor: 
has dmc: No
This study assessed the effect on asthma control of different dose levels and regimens of
      QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2
      agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab.
      Information from this study was planned to support the design of future studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo
time frame: Week 16
description: The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
measure: Change From Baseline in ACQ-7 Score
time frame: Baseline, Weeks 4, 8, 12, 16 and 28
description: The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.
measure: Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1
time frame: Week 16
description: The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.
measure: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score
time frame: Baseline, Week 16, Week 28
description: The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.
measure: Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication
time frame: Baseline, Week 16
description: Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.
arm group label: QGE031 240 mg every 2 weeks (q2w)
arm group type: Experimental
description: Participants received QGE031 240 mg subcutaneously (s.c.) q2w for 16 weeks.
arm group label: QGE031 240 mg q4w
arm group type: Experimental
description: Participants received QGE031 240 mg s.c. q4w for 16 weeks.
arm group label: QGE031 180 mg q2w
arm group type: Experimental
description: Participants received QGE031 180 mg s.c. q2w for 16 weeks.
arm group label: QGE031 120 mg q2w
arm group type: Experimental
description: Participants received QGE031 120 mg s.c. q2w for 16 weeks.
arm group label: QGE031 36 mg q2w
arm group type: Experimental
description: Participants received QGE031 36 mg s.c. q2w for 16 weeks.
arm group label: QGE031 12 mg q2w
arm group type: Experimental
description: Participants received QGE031 12 mg s.c. q2w for 16 weeks.
arm group label: Omalizumab (as per locally approved dosing table)
arm group type: Active Comparator
description: Participants received omalizumab as per locally approved dosing table s.c. q2w or q4w for 16 weeks.
arm group label: Placebo to QGE031 240 mg q2w
arm group type: Placebo Comparator
description: Participants received matching placebo to QGE031 240 mg s.c. q2w for 16 weeks.
arm group label: Placebo to QGE031 240 mg q4w
arm group type: Placebo Comparator
description: Participants received placebo to QGE031 240 mg s.c. q2w for 16 weeks.
arm group label: Placebo to QGE031 180 mg q2w
arm group type: Placebo Comparator
description: Participants received QGE031 180 mg s.c. q2w for 16 weeks.
arm group label: Placebo to QGE031 120 mg q2w
arm group type: Placebo Comparator
description: Participants received QGE031 120 mg s.c. q2w for 16 weeks.
arm group label: Placebo to QGE031 36 mg q2w
arm group type: Placebo Comparator
description: Participants received QGE031 36 mg s.c. q2w for 16 weeks.
arm group label: Placebo to QGE031 12 mg q2w
arm group type: Placebo Comparator
description: Participants received QGE031 12 mg s.c. q2w for 16 weeks.
arm group label: Placebo to omalizumab
arm group type: Placebo Comparator
description: Participants received placebo to omalizumab s.c. q2w or q4w for 16 weeks.
intervention type: Drug
intervention name: QGE031
description: QGE031 was supplied as 120 mg liquid in vial per 1 mL
arm group label: QGE031 12 mg q2w
arm group label: QGE031 120 mg q2w
arm group label: QGE031 180 mg q2w
arm group label: QGE031 240 mg every 2 weeks (q2w)
arm group label: QGE031 240 mg q4w
arm group label: QGE031 36 mg q2w
intervention type: Drug
intervention name: Omalizumab
description: Omalizumab was supplied as 150 mg lyophilisate in vial
arm group label: Omalizumab (as per locally approved dosing table)
other name: Xolair
intervention type: Drug
intervention name: Placebo
description: Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
arm group label: Placebo to QGE031 12 mg q2w
arm group label: Placebo to QGE031 120 mg q2w
arm group label: Placebo to QGE031 180 mg q2w
arm group label: Placebo to QGE031 240 mg q2w
arm group label: Placebo to QGE031 240 mg q4w
arm group label: Placebo to QGE031 36 mg q2w
arm group label: Placebo to omalizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Argentina
country: Canada
country: Czechia
country: Finland
country: France
country: Germany
country: Guatemala
country: Hungary
country: India
country: Israel
country: Italy
country: Korea, Republic of
country: Mexico
country: Panama
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Singapore
country: Slovakia
country: South Africa
country: Turkey
country: United Kingdom
country: United States
country: Czech Republic
country: Denmark
country: Spain
responsible party type: Sponsor
mesh term: Asthma
mesh term: Omalizumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 