<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/NCT01712516</url>
  </required_header>
  <id_info>
    <org_study_id>CQVA149A2337</org_study_id>
    <nct_id>NCT01712516</nct_id>
  </id_info>
  <brief_title>A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation</brief_title>
  <official_title>A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation</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 will assess the efficacy, safety and tolerability of indacaterol&#xD;
      maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))</measure>
    <time_frame>baseline (BL), 12 weeks</time_frame>
    <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score</measure>
    <time_frame>BL, 12 Weeks</time_frame>
    <description>Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers &quot;Symptoms&quot; and is concerned with respiratory symptoms, their frequency and severity; Part II covers &quot;Activity&quot; and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with &quot;Impacts&quot;, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a &quot;Total&quot; score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day &gt;= 29. A negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers &quot;Symptoms&quot; and is concerned with respiratory symptoms, their frequency and severity; Part II covers &quot;Activity&quot; and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with &quot;Impacts&quot;, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a &quot;Total&quot; score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Trough FEV1</measure>
    <time_frame>BL, day 2, day 86</time_frame>
    <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pre-dose Trough FEV1</measure>
    <time_frame>BL, day 85</time_frame>
    <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FEV1</measure>
    <time_frame>BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min</time_frame>
    <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FVC</measure>
    <time_frame>BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min</time_frame>
    <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)</measure>
    <time_frame>BL, day 1, 12 weeks</time_frame>
    <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transitional Dyspnea Index (TDI) Focal Score</measure>
    <time_frame>BL, 12 weeks</time_frame>
    <description>The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication</measure>
    <time_frame>BL, 12 weeks</time_frame>
    <description>Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score</measure>
    <time_frame>BL, 12 weeks</time_frame>
    <description>The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1001</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>QVA149</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>27.5/12.5 ug twice daily (b.i.d.) Single Dose Dry Powder Inhaler (SDDPI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QAB149</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>27.5 ug b.i.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NVA237</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12.5 ug b.i.d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>b.i.d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QVA149</intervention_name>
    <description>QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI</description>
    <arm_group_label>QVA149</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QAB149</intervention_name>
    <description>QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.</description>
    <arm_group_label>QAB149</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NVA237</intervention_name>
    <description>NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.</description>
    <arm_group_label>NVA237</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients that have signed informed consent and are &gt;/= 40 years of&#xD;
             age.&#xD;
&#xD;
          -  Patients with stable COPD according to GOLD 2011.&#xD;
&#xD;
          -  Patients with a post-bronchodilator FEV1 of &gt;/= 30% and &lt; 80% predicted and a&#xD;
             post-bronchodilator FEV1/FVC &lt;0.70.&#xD;
&#xD;
          -  Current or ex-smokers who have a smoking history of at least 10 pack years.&#xD;
&#xD;
          -  Patients with an mMRC grade 2 or greater.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Type I or uncontrolled Type II diabetes - Patients with a history of&#xD;
             long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged&#xD;
             (&gt;450 ms for males and females) and confirmed by a central assessor. (These patients&#xD;
             should not be re-screened.)&#xD;
&#xD;
          -  Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102.&#xD;
             (These patients should not be re-screened.)&#xD;
&#xD;
          -  Patients with a history of malignancy of any organ system, treated or untreated,&#xD;
             within the last five years.&#xD;
&#xD;
          -  Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or&#xD;
             moderate-severe renal impairment or urinary retention.&#xD;
&#xD;
          -  Patients who had a COPD exacerbation within 6 weeks prior to screening.&#xD;
&#xD;
          -  Patients who have a respiratory tract infection within 4 weeks prior to screening.&#xD;
&#xD;
          -  Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.&#xD;
&#xD;
          -  Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms,&#xD;
             including COPD diagnosis, prior to age 40 years.&#xD;
&#xD;
          -  Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.&#xD;
&#xD;
          -  Patients with concomitant pulmonary disease.&#xD;
&#xD;
          -  Patients with a diagnosis of alpha-1 anti-trypsin deficiency.&#xD;
&#xD;
          -  Patients with active pulmonary tuberculosis.&#xD;
&#xD;
          -  Patients in the active phase of a pulmonary rehabilitation programme.&#xD;
&#xD;
          -  Other protocol-defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</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>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>*See Various Dept.'s*</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Palmdale</city>
        <state>California</state>
        <zip>93551</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 Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sepulveda</city>
        <state>California</state>
        <zip>91343</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Deland</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ft. Lauderdale</city>
        <state>Florida</state>
        <zip>33316-192</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Opelousas</city>
        <state>Louisiana</state>
        <zip>70570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brandon</city>
        <state>New Jersey</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406-7108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Easley</city>
        <state>South Carolina</state>
        <zip>29640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gaffney</city>
        <state>South Carolina</state>
        <zip>29340</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pelzer</city>
        <state>South Carolina</state>
        <zip>29669</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rock Hll</city>
        <state>South Carolina</state>
        <zip>29732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seneca</city>
        <state>South Carolina</state>
        <zip>29678</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Simpsonville</city>
        <state>South Carolina</state>
        <zip>29681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Union</city>
        <state>South Carolina</state>
        <zip>29379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Corsicana</city>
        <state>Texas</state>
        <zip>75110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ft. Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lufkin</city>
        <state>Texas</state>
        <zip>75904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlantico</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Armenia</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barranquilla</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Alexandria</city>
        <zip>21131</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Beuvry</city>
        <zip>62660</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <zip>01010</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>Guatemala City</city>
        <zip>01015</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Balassagyarmat</city>
        <zip>2660</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>Deszk</city>
        <zip>6772</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Godollo</city>
        <zip>2100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gyor</city>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Komarom</city>
        <zip>2900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mako</city>
        <zip>6900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Miskolc</city>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Szazhalombatta</city>
        <zip>2440</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Szombathely</city>
        <zip>9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tatabanya</city>
        <zip>2800</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Panama City</city>
        <state>Panamá</state>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bardejov</city>
        <state>Slovak Republic</state>
        <zip>085 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bojnice</city>
        <state>Slovak Republic</state>
        <zip>972 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Humenne</city>
        <state>Slovak Republic</state>
        <zip>066 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Liptovsky Hradok</city>
        <state>Slovak Republic</state>
        <zip>033 01</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>Vrable</city>
        <state>Slovak Republic</state>
        <zip>952 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Galanta</city>
        <zip>92422</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kosice</city>
        <zip>040 01</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>Kralovsky Chlmec</city>
        <zip>077 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Martin</city>
        <zip>036 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Presov</city>
        <zip>080 01</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>Spisská Nová Ves</city>
        <zip>052 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Zvolen</city>
        <zip>960 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Golnik</city>
        <zip>4204</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
    <country>Egypt</country>
    <country>France</country>
    <country>Guatemala</country>
    <country>Hungary</country>
    <country>Panama</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Mexico</country>
  </removed_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>May 27, 2015</results_first_submitted>
  <results_first_submitted_qc>July 13, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 15, 2015</results_first_posted>
  <last_update_submitted>July 13, 2015</last_update_submitted>
  <last_update_submitted_qc>July 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD, QVA149</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glycopyrrolate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were randomized to each treatment arm in a 1:1:1:1 ratio.</recruitment_details>
      <pre_assignment_details>One thousand one participants were randomized. (One participant was randomized twice, took study drug twice and was counted twice in the randomized and safety sets). In the safety set, participants were analyzed according to the treatment received.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>QVA149</title>
          <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
        </group>
        <group group_id="P2">
          <title>QAB149</title>
          <description>27.5 ug b.i.d.</description>
        </group>
        <group group_id="P3">
          <title>NVA237</title>
          <description>12.5 ug b.i.d.</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>b.i.d.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="250"/>
                <participants group_id="P2" count="251"/>
                <participants group_id="P3" count="251"/>
                <participants group_id="P4" count="249"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set</title>
              <participants_list>
                <participants group_id="P1" count="250"/>
                <participants group_id="P2" count="251"/>
                <participants group_id="P3" count="251"/>
                <participants group_id="P4" count="248"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="250"/>
                <participants group_id="P2" count="251"/>
                <participants group_id="P3" count="250"/>
                <participants group_id="P4" count="247"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="244"/>
                <participants group_id="P2" count="241"/>
                <participants group_id="P3" count="245"/>
                <participants group_id="P4" count="236"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Technical problems</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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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="2"/>
                <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>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>QVA149</title>
          <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
        </group>
        <group group_id="B2">
          <title>QAB149</title>
          <description>27.5 ug b.i.d.</description>
        </group>
        <group group_id="B3">
          <title>NVA237</title>
          <description>12.5 ug b.i.d.</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>b.i.d.</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="250"/>
            <count group_id="B2" value="251"/>
            <count group_id="B3" value="251"/>
            <count group_id="B4" value="249"/>
            <count group_id="B5" value="1001"/>
          </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="62.8" spread="8.46"/>
                    <measurement group_id="B2" value="63.7" spread="8.58"/>
                    <measurement group_id="B3" value="63.1" spread="8.53"/>
                    <measurement group_id="B4" value="62.5" spread="8.07"/>
                    <measurement group_id="B5" value="63.0" spread="8.41"/>
                  </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="96"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="107"/>
                    <measurement group_id="B4" value="111"/>
                    <measurement group_id="B5" value="415"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="144"/>
                    <measurement group_id="B4" value="138"/>
                    <measurement group_id="B5" value="586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))</title>
        <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.</description>
        <time_frame>baseline (BL), 12 weeks</time_frame>
        <population>Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))</title>
          <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.</description>
          <population>Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="249"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="250"/>
                <count group_id="O4" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.234" spread="0.0134"/>
                    <measurement group_id="O2" value="0.122" spread="0.0134"/>
                    <measurement group_id="O3" value="0.155" spread="0.0134"/>
                    <measurement group_id="O4" value="-0.028" spread="0.0137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score</title>
        <description>Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers &quot;Symptoms&quot; and is concerned with respiratory symptoms, their frequency and severity; Part II covers &quot;Activity&quot; and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with &quot;Impacts&quot;, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a &quot;Total&quot; score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day &gt;= 29. A negative change from baseline indicates improvement.</description>
        <time_frame>BL, 12 Weeks</time_frame>
        <population>Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score</title>
          <description>Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers &quot;Symptoms&quot; and is concerned with respiratory symptoms, their frequency and severity; Part II covers &quot;Activity&quot; and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with &quot;Impacts&quot;, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a &quot;Total&quot; score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day &gt;= 29. A negative change from baseline indicates improvement.</description>
          <population>Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.</population>
          <units>score on a scale</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="238"/>
                <count group_id="O2" value="234"/>
                <count group_id="O3" value="237"/>
                <count group_id="O4" value="226"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="0.85"/>
                    <measurement group_id="O2" value="-5.9" spread="0.86"/>
                    <measurement group_id="O3" value="-6.0" spread="0.86"/>
                    <measurement group_id="O4" value="-1.1" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score</title>
        <description>Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers &quot;Symptoms&quot; and is concerned with respiratory symptoms, their frequency and severity; Part II covers &quot;Activity&quot; and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with &quot;Impacts&quot;, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a &quot;Total&quot; score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.</description>
        <time_frame>12 weeks</time_frame>
        <population>Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score</title>
          <description>Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers &quot;Symptoms&quot; and is concerned with respiratory symptoms, their frequency and severity; Part II covers &quot;Activity&quot; and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with &quot;Impacts&quot;, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a &quot;Total&quot; score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.</description>
          <population>Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.</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="238"/>
                <count group_id="O2" value="234"/>
                <count group_id="O3" value="237"/>
                <count group_id="O4" value="226"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2"/>
                    <measurement group_id="O2" value="56.8"/>
                    <measurement group_id="O3" value="51.5"/>
                    <measurement group_id="O4" value="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Trough FEV1</title>
        <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.</description>
        <time_frame>BL, day 2, day 86</time_frame>
        <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Trough FEV1</title>
          <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.</description>
          <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="249"/>
                <count group_id="O4" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.208" spread="0.0107"/>
                    <measurement group_id="O2" value="0.111" spread="0.0106"/>
                    <measurement group_id="O3" value="0.132" spread="0.0107"/>
                    <measurement group_id="O4" value="0.010" spread="0.0107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 86</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.216" spread="0.0142"/>
                    <measurement group_id="O2" value="0.138" spread="0.0141"/>
                    <measurement group_id="O3" value="0.128" spread="0.0142"/>
                    <measurement group_id="O4" value="-0.017" spread="0.0145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pre-dose Trough FEV1</title>
        <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.</description>
        <time_frame>BL, day 85</time_frame>
        <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pre-dose Trough FEV1</title>
          <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.</description>
          <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="243"/>
                <count group_id="O2" value="249"/>
                <count group_id="O3" value="246"/>
                <count group_id="O4" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.193" spread="0.0132"/>
                    <measurement group_id="O2" value="0.100" spread="0.0132"/>
                    <measurement group_id="O3" value="0.108" spread="0.0133"/>
                    <measurement group_id="O4" value="-0.027" spread="0.0135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FEV1</title>
        <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.</description>
        <time_frame>BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min</time_frame>
        <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FEV1</title>
          <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.</description>
          <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="250"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="250"/>
                <count group_id="O4" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>day 1, 5 min (n=248,249,249,243)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.117" spread="0.0061"/>
                    <measurement group_id="O2" value="0.076" spread="0.0060"/>
                    <measurement group_id="O3" value="0.072" spread="0.0061"/>
                    <measurement group_id="O4" value="-0.001" spread="0.0062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 15 min (n=248,251,249,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.160" spread="0.0070"/>
                    <measurement group_id="O2" value="0.090" spread="0.0069"/>
                    <measurement group_id="O3" value="0.126" spread="0.0070"/>
                    <measurement group_id="O4" value="0.005" spread="0.0070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.199" spread="0.0082"/>
                    <measurement group_id="O2" value="0.089" spread="0.0082"/>
                    <measurement group_id="O3" value="0.176" spread="0.0083"/>
                    <measurement group_id="O4" value="0.008" spread="0.0083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 2 h (n=249,249,248,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.237" spread="0.0091"/>
                    <measurement group_id="O2" value="0.109" spread="0.0091"/>
                    <measurement group_id="O3" value="0.197" spread="0.0092"/>
                    <measurement group_id="O4" value="0.030" spread="0.0092"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 4 h (n=247,247,248,237)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.220" spread="0.0099"/>
                    <measurement group_id="O2" value="0.108" spread="0.0099"/>
                    <measurement group_id="O3" value="0.167" spread="0.0099"/>
                    <measurement group_id="O4" value="0.019" spread="0.0101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 6 h (n=247,246,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.181" spread="0.0103"/>
                    <measurement group_id="O2" value="0.085" spread="0.0104"/>
                    <measurement group_id="O3" value="0.135" spread="0.0104"/>
                    <measurement group_id="O4" value="-0.005" spread="0.0106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 8 h (n=248,247,245,242)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.165" spread="0.0102"/>
                    <measurement group_id="O2" value="0.077" spread="0.0101"/>
                    <measurement group_id="O3" value="0.112" spread="0.0103"/>
                    <measurement group_id="O4" value="-0.019" spread="0.0104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 11 h 55 min(n=242,243,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.116" spread="0.0114"/>
                    <measurement group_id="O2" value="0.029" spread="0.0114"/>
                    <measurement group_id="O3" value="0.066" spread="0.0114"/>
                    <measurement group_id="O4" value="-0.045" spread="0.0115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 2, 23 h 15 min (n=241,246,245,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.201" spread="0.0111"/>
                    <measurement group_id="O2" value="0.105" spread="0.0110"/>
                    <measurement group_id="O3" value="0.128" spread="0.0111"/>
                    <measurement group_id="O4" value="0.002" spread="0.0111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 2, 23 h 45 min (n= 246,251,248,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.216" spread="0.0111"/>
                    <measurement group_id="O2" value="0.118" spread="0.0109"/>
                    <measurement group_id="O3" value="0.137" spread="0.0111"/>
                    <measurement group_id="O4" value="0.018" spread="0.0111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 15, - 45 min (243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.208" spread="0.0126"/>
                    <measurement group_id="O2" value="0.114" spread="0.0124"/>
                    <measurement group_id="O3" value="0.108" spread="0.0126"/>
                    <measurement group_id="O4" value="-0.045" spread="0.0127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 15, -15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.238" spread="0.0124"/>
                    <measurement group_id="O2" value="0.143" spread="0.0123"/>
                    <measurement group_id="O3" value="0.132" spread="0.0124"/>
                    <measurement group_id="O4" value="-0.025" spread="0.0124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 15, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.321" spread="0.0134"/>
                    <measurement group_id="O2" value="0.179" spread="0.0133"/>
                    <measurement group_id="O3" value="0.212" spread="0.0134"/>
                    <measurement group_id="O4" value="-0.019" spread="0.0135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 29, -45 min (n=243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.213" spread="0.0132"/>
                    <measurement group_id="O2" value="0.127" spread="0.0131"/>
                    <measurement group_id="O3" value="0.117" spread="0.0132"/>
                    <measurement group_id="O4" value="-0.030" spread="0.0133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 29, -15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.235" spread="0.0132"/>
                    <measurement group_id="O2" value="0.147" spread="0.0131"/>
                    <measurement group_id="O3" value="0.138" spread="0.0132"/>
                    <measurement group_id="O4" value="-0.013" spread="0.0134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 29, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.320" spread="0.0135"/>
                    <measurement group_id="O2" value="0.170" spread="0.0135"/>
                    <measurement group_id="O3" value="0.216" spread="0.0136"/>
                    <measurement group_id="O4" value="-0.004" spread="0.0137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 57, -45 min (n=243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.203" spread="0.0136"/>
                    <measurement group_id="O2" value="0.104" spread="0.0136"/>
                    <measurement group_id="O3" value="0.117" spread="0.0137"/>
                    <measurement group_id="O4" value="-0.037" spread="0.0140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 57, -15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.224" spread="0.0136"/>
                    <measurement group_id="O2" value="0.125" spread="0.0135"/>
                    <measurement group_id="O3" value="0.147" spread="0.0136"/>
                    <measurement group_id="O4" value="-0.014" spread="0.0139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 57, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.319" spread="0.0143"/>
                    <measurement group_id="O2" value="0.163" spread="0.0143"/>
                    <measurement group_id="O3" value="0.221" spread="0.0144"/>
                    <measurement group_id="O4" value="-0.016" spread="0.0146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, -45 min (n=243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.187" spread="0.0134"/>
                    <measurement group_id="O2" value="0.090" spread="0.0135"/>
                    <measurement group_id="O3" value="0.096" spread="0.0135"/>
                    <measurement group_id="O4" value="-0.032" spread="0.0138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, - 15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.199" spread="0.0138"/>
                    <measurement group_id="O2" value="0.109" spread="0.0137"/>
                    <measurement group_id="O3" value="0.123" spread="0.0138"/>
                    <measurement group_id="O4" value="-0.018" spread="0.0141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 5 min (n=248,249,249,243)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.246" spread="0.0142"/>
                    <measurement group_id="O2" value="0.151" spread="0.0143"/>
                    <measurement group_id="O3" value="0.143" spread="0.0142"/>
                    <measurement group_id="O4" value="-0.020" spread="0.0144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 15 min (n=248,251,249,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.269" spread="0.0141"/>
                    <measurement group_id="O2" value="0.153" spread="0.0142"/>
                    <measurement group_id="O3" value="0.179" spread="0.0141"/>
                    <measurement group_id="O4" value="-0.001" spread="0.0145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.293" spread="0.0144"/>
                    <measurement group_id="O2" value="0.141" spread="0.0144"/>
                    <measurement group_id="O3" value="0.208" spread="0.0144"/>
                    <measurement group_id="O4" value="-0.018" spread="0.0147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 2 h (n=249,249,248,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.315" spread="0.0146"/>
                    <measurement group_id="O2" value="0.159" spread="0.0147"/>
                    <measurement group_id="O3" value="0.216" spread="0.0148"/>
                    <measurement group_id="O4" value="-0.001" spread="0.0150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 4 h (n=247,247,248,237)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.260" spread="0.0150"/>
                    <measurement group_id="O2" value="0.145" spread="0.0151"/>
                    <measurement group_id="O3" value="0.172" spread="0.0151"/>
                    <measurement group_id="O4" value="-0.004" spread="0.0157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 6 h (n=247,246,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.226" spread="0.0149"/>
                    <measurement group_id="O2" value="0.122" spread="0.0150"/>
                    <measurement group_id="O3" value="0.139" spread="0.0151"/>
                    <measurement group_id="O4" value="-0.011" spread="0.0155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 8 h (n=248,247,245,242)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.198" spread="0.0146"/>
                    <measurement group_id="O2" value="0.107" spread="0.0147"/>
                    <measurement group_id="O3" value="0.133" spread="0.0149"/>
                    <measurement group_id="O4" value="-0.039" spread="0.0153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 11 h 55 min(n=242,243,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.163" spread="0.0147"/>
                    <measurement group_id="O2" value="0.078" spread="0.0150"/>
                    <measurement group_id="O3" value="0.105" spread="0.0150"/>
                    <measurement group_id="O4" value="-0.073" spread="0.0154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 86, 23 h 15 min (n=241,246,245,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.206" spread="0.0148"/>
                    <measurement group_id="O2" value="0.130" spread="0.0147"/>
                    <measurement group_id="O3" value="0.117" spread="0.0149"/>
                    <measurement group_id="O4" value="-0.023" spread="0.0150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 86, 23 h 45 min (n=246,251,248,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.221" spread="0.0144"/>
                    <measurement group_id="O2" value="0.144" spread="0.0144"/>
                    <measurement group_id="O3" value="0.132" spread="0.0146"/>
                    <measurement group_id="O4" value="-0.012" spread="0.0149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FVC</title>
        <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.</description>
        <time_frame>BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min</time_frame>
        <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FVC</title>
          <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.</description>
          <population>Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="250"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="250"/>
                <count group_id="O4" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>day 1, 5 min (n=248,249,249,243)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.245" spread="0.0138"/>
                    <measurement group_id="O2" value="0.175" spread="0.0136"/>
                    <measurement group_id="O3" value="0.158" spread="0.0137"/>
                    <measurement group_id="O4" value="-0.006" spread="0.0140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 15 min (n=248,251,249,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.318" spread="0.0154"/>
                    <measurement group_id="O2" value="0.185" spread="0.0153"/>
                    <measurement group_id="O3" value="0.238" spread="0.0155"/>
                    <measurement group_id="O4" value="0.009" spread="0.0155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.355" spread="0.0165"/>
                    <measurement group_id="O2" value="0.153" spread="0.0164"/>
                    <measurement group_id="O3" value="0.309" spread="0.0166"/>
                    <measurement group_id="O4" value="0.013" spread="0.0166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 2 h (n=249,249,248,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.395" spread="0.0181"/>
                    <measurement group_id="O2" value="0.214" spread="0.0180"/>
                    <measurement group_id="O3" value="0.324" spread="0.0182"/>
                    <measurement group_id="O4" value="0.044" spread="0.0183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 4 h (n=247,247,248,237)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.364" spread="0.0187"/>
                    <measurement group_id="O2" value="0.189" spread="0.0187"/>
                    <measurement group_id="O3" value="0.271" spread="0.0188"/>
                    <measurement group_id="O4" value="0.026" spread="0.0192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 6 h (n=247,246,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.316" spread="0.0186"/>
                    <measurement group_id="O2" value="0.159" spread="0.0188"/>
                    <measurement group_id="O3" value="0.244" spread="0.0189"/>
                    <measurement group_id="O4" value="0.004" spread="0.0192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 8 h (n=248,247,245,242)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.285" spread="0.0179"/>
                    <measurement group_id="O2" value="0.154" spread="0.0178"/>
                    <measurement group_id="O3" value="0.212" spread="0.0182"/>
                    <measurement group_id="O4" value="-0.021" spread="0.0183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 1, 11 h 55 min (n=242,243,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.235" spread="0.0188"/>
                    <measurement group_id="O2" value="0.093" spread="0.0188"/>
                    <measurement group_id="O3" value="0.125" spread="0.0188"/>
                    <measurement group_id="O4" value="-0.060" spread="0.0190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 2, 23 h 15 min (n=241,246,245,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.343" spread="0.0193"/>
                    <measurement group_id="O2" value="0.191" spread="0.0191"/>
                    <measurement group_id="O3" value="0.217" spread="0.0194"/>
                    <measurement group_id="O4" value="0.001" spread="0.0194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 2, 23 h 45 min (n=246,251,248,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.355" spread="0.0195"/>
                    <measurement group_id="O2" value="0.196" spread="0.0192"/>
                    <measurement group_id="O3" value="0.229" spread="0.0194"/>
                    <measurement group_id="O4" value="0.027" spread="0.0195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 15, -45 min (n=243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.313" spread="0.0205"/>
                    <measurement group_id="O2" value="0.163" spread="0.0201"/>
                    <measurement group_id="O3" value="0.168" spread="0.0204"/>
                    <measurement group_id="O4" value="-0.047" spread="0.0206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 15, -15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.358" spread="0.0207"/>
                    <measurement group_id="O2" value="0.201" spread="0.0204"/>
                    <measurement group_id="O3" value="0.198" spread="0.0207"/>
                    <measurement group_id="O4" value="-0.020" spread="0.0207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 15, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.473" spread="0.0025"/>
                    <measurement group_id="O2" value="0.269" spread="0.0223"/>
                    <measurement group_id="O3" value="0.311" spread="0.0225"/>
                    <measurement group_id="O4" value="-0.009" spread="0.0227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 29, -45 min (n=243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.320" spread="0.0217"/>
                    <measurement group_id="O2" value="0.194" spread="0.0216"/>
                    <measurement group_id="O3" value="0.188" spread="0.0217"/>
                    <measurement group_id="O4" value="-0.025" spread="0.0220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 29, -15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.332" spread="0.0216"/>
                    <measurement group_id="O2" value="0.218" spread="0.0215"/>
                    <measurement group_id="O3" value="0.197" spread="0.0216"/>
                    <measurement group_id="O4" value="-0.004" spread="0.0219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 29, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.449" spread="0.0224"/>
                    <measurement group_id="O2" value="0.259" spread="0.0223"/>
                    <measurement group_id="O3" value="0.322" spread="0.0225"/>
                    <measurement group_id="O4" value="0.008" spread="0.0227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 57, -45 min (n=243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.293" spread="0.0215"/>
                    <measurement group_id="O2" value="0.142" spread="0.0215"/>
                    <measurement group_id="O3" value="0.173" spread="0.0217"/>
                    <measurement group_id="O4" value="-0.034" spread="0.0221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 57, -15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.298" spread="0.0223"/>
                    <measurement group_id="O2" value="0.167" spread="0.0222"/>
                    <measurement group_id="O3" value="0.222" spread="0.0224"/>
                    <measurement group_id="O4" value="-0.009" spread="0.0229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 57, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.445" spread="0.0233"/>
                    <measurement group_id="O2" value="0.227" spread="0.0233"/>
                    <measurement group_id="O3" value="0.326" spread="0.0234"/>
                    <measurement group_id="O4" value="-0.011" spread="0.0238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, -45 min (n=243,249,246,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.252" spread="0.0223"/>
                    <measurement group_id="O2" value="0.121" spread="0.0224"/>
                    <measurement group_id="O3" value="0.143" spread="0.0225"/>
                    <measurement group_id="O4" value="-0.029" spread="0.0229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, -15 min (n=243,248,246,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.263" spread="0.0224"/>
                    <measurement group_id="O2" value="0.142" spread="0.0223"/>
                    <measurement group_id="O3" value="0.180" spread="0.0225"/>
                    <measurement group_id="O4" value="-0.031" spread="0.0229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 5 min (n=248,249,249,243)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.331" spread="0.0243"/>
                    <measurement group_id="O2" value="0.215" spread="0.0244"/>
                    <measurement group_id="O3" value="0.225" spread="0.0243"/>
                    <measurement group_id="O4" value="-0.048" spread="0.0247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 15 min (n=248,251,249,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.377" spread="0.0242"/>
                    <measurement group_id="O2" value="0.223" spread="0.0243"/>
                    <measurement group_id="O3" value="0.276" spread="0.0243"/>
                    <measurement group_id="O4" value="-0.004" spread="0.0248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 1 h (n=249,251,249,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.400" spread="0.0243"/>
                    <measurement group_id="O2" value="0.209" spread="0.0243"/>
                    <measurement group_id="O3" value="0.295" spread="0.0244"/>
                    <measurement group_id="O4" value="-0.023" spread="0.0248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 2h (n=249,249,248,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.414" spread="0.0244"/>
                    <measurement group_id="O2" value="0.218" spread="0.0245"/>
                    <measurement group_id="O3" value="0.301" spread="0.0247"/>
                    <measurement group_id="O4" value="-0.001" spread="0.0251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 4 h (n=247,247,248,237)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.338" spread="0.0247"/>
                    <measurement group_id="O2" value="0.203" spread="0.0249"/>
                    <measurement group_id="O3" value="0.261" spread="0.0250"/>
                    <measurement group_id="O4" value="0.002" spread="0.0259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 6 h (n=247,246,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.305" spread="0.0239"/>
                    <measurement group_id="O2" value="0.164" spread="0.0240"/>
                    <measurement group_id="O3" value="0.211" spread="0.0241"/>
                    <measurement group_id="O4" value="-0.011" spread="0.0248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 8 h (n=248,247,245,242)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.273" spread="0.0233"/>
                    <measurement group_id="O2" value="0.152" spread="0.0235"/>
                    <measurement group_id="O3" value="0.213" spread="0.0237"/>
                    <measurement group_id="O4" value="-0.038" spread="0.0244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 85, 11 55 min (n=242,243,244,239)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.233" spread="0.0239"/>
                    <measurement group_id="O2" value="0.131" spread="0.0243"/>
                    <measurement group_id="O3" value="0.197" spread="0.0243"/>
                    <measurement group_id="O4" value="-0.093" spread="0.0250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 86, 23 h 15 min (n=241,246,245,241)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.278" spread="0.0248"/>
                    <measurement group_id="O2" value="0.172" spread="0.0247"/>
                    <measurement group_id="O3" value="0.176" spread="0.0250"/>
                    <measurement group_id="O4" value="-0.021" spread="0.0251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>day 86, 23 h 45 min (n=246,251,248,244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.298" spread="0.0240"/>
                    <measurement group_id="O2" value="0.199" spread="0.0239"/>
                    <measurement group_id="O3" value="0.210" spread="0.0244"/>
                    <measurement group_id="O4" value="-0.017" spread="0.0248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)</title>
        <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.</description>
        <time_frame>BL, day 1, 12 weeks</time_frame>
        <population>Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)</title>
          <description>Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.</description>
          <population>Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.</population>
          <units>Liters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="250"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="250"/>
                <count group_id="O4" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, AUC 0-4h (n=249,251,250,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.213" spread="0.0077"/>
                    <measurement group_id="O2" value="0.101" spread="0.0077"/>
                    <measurement group_id="O3" value="0.174" spread="0.0077"/>
                    <measurement group_id="O4" value="0.019" spread="0.0078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, AUC 4-8h (n=248,248,250,243)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.187" spread="0.0093"/>
                    <measurement group_id="O2" value="0.090" spread="0.0093"/>
                    <measurement group_id="O3" value="0.134" spread="0.0093"/>
                    <measurement group_id="O4" value="-0.003" spread="0.0095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, AUC 8-12h (n=248,249,249,245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.143" spread="0.0099"/>
                    <measurement group_id="O2" value="0.054" spread="0.0099"/>
                    <measurement group_id="O3" value="0.092" spread="0.0100"/>
                    <measurement group_id="O4" value="-0.031" spread="0.0101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, AUC 0-12h (n=249,251,250,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.184" spread="0.0084"/>
                    <measurement group_id="O2" value="0.080" spread="0.0084"/>
                    <measurement group_id="O3" value="0.135" spread="0.0084"/>
                    <measurement group_id="O4" value="-0.003" spread="0.0085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, AUC 0-4h (n=249,251,250,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.289" spread="0.0138"/>
                    <measurement group_id="O2" value="0.147" spread="0.0138"/>
                    <measurement group_id="O3" value="0.196" spread="0.0138"/>
                    <measurement group_id="O4" value="-0.008" spread="0.0141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, AUC 4-8h (n=248,248,250,243)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.229" spread="0.0140"/>
                    <measurement group_id="O2" value="0.120" spread="0.0141"/>
                    <measurement group_id="O3" value="0.148" spread="0.0141"/>
                    <measurement group_id="O4" value="-0.021" spread="0.0145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, AUC 8-12h (n=248,249,249,245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.182" spread="0.0141"/>
                    <measurement group_id="O2" value="0.095" spread="0.0142"/>
                    <measurement group_id="O3" value="0.123" spread="0.0143"/>
                    <measurement group_id="O4" value="-0.055" spread="0.0146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, AUC 0-12h (n=249,251,250,246)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.234" spread="0.0134"/>
                    <measurement group_id="O2" value="0.122" spread="0.0134"/>
                    <measurement group_id="O3" value="0.155" spread="0.0134"/>
                    <measurement group_id="O4" value="-0.028" spread="0.0137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Transitional Dyspnea Index (TDI) Focal Score</title>
        <description>The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.</description>
        <time_frame>BL, 12 weeks</time_frame>
        <population>Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Transitional Dyspnea Index (TDI) Focal Score</title>
          <description>The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.</description>
          <population>Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.</population>
          <units>score on a scale</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="233"/>
                <count group_id="O2" value="238"/>
                <count group_id="O3" value="232"/>
                <count group_id="O4" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.88" spread="0.251"/>
                    <measurement group_id="O2" value="1.98" spread="0.252"/>
                    <measurement group_id="O3" value="1.88" spread="0.252"/>
                    <measurement group_id="O4" value="0.85" spread="0.256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication</title>
        <description>Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.</description>
        <time_frame>BL, 12 weeks</time_frame>
        <population>Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication</title>
          <description>Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.</description>
          <population>Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.</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="243"/>
                <count group_id="O2" value="242"/>
                <count group_id="O3" value="242"/>
                <count group_id="O4" value="235"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.19" spread="0.150"/>
                    <measurement group_id="O2" value="-2.05" spread="0.150"/>
                    <measurement group_id="O3" value="-1.78" spread="0.151"/>
                    <measurement group_id="O4" value="-1.04" spread="0.153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score</title>
        <description>The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.</description>
        <time_frame>BL, 12 weeks</time_frame>
        <population>Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>QVA149</title>
            <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
          </group>
          <group group_id="O2">
            <title>QAB149</title>
            <description>27.5 ug b.i.d.</description>
          </group>
          <group group_id="O3">
            <title>NVA237</title>
            <description>12.5 ug b.i.d.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>b.i.d.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score</title>
          <description>The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.</description>
          <population>Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.</population>
          <units>score on a scale</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="250"/>
                <count group_id="O2" value="251"/>
                <count group_id="O3" value="250"/>
                <count group_id="O4" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>total daily (n=243,242,242,235)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="0.108"/>
                    <measurement group_id="O2" value="-1.22" spread="0.108"/>
                    <measurement group_id="O3" value="-1.09" spread="0.108"/>
                    <measurement group_id="O4" value="-0.61" spread="0.110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>total daytime (n=242,239,240,234)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.16" spread="0.105"/>
                    <measurement group_id="O2" value="-1.05" spread="0.105"/>
                    <measurement group_id="O3" value="-0.96" spread="0.105"/>
                    <measurement group_id="O4" value="-0.53" spread="0.106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>total nighttime (n=243,239,238,234)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.09" spread="0.107"/>
                    <measurement group_id="O2" value="-1.01" spread="0.107"/>
                    <measurement group_id="O3" value="-0.90" spread="0.108"/>
                    <measurement group_id="O4" value="-0.41" spread="0.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>QVA149</title>
          <description>27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)</description>
        </group>
        <group group_id="E2">
          <title>QAB149</title>
          <description>27.5 ug b.i.d.</description>
        </group>
        <group group_id="E3">
          <title>NVA237</title>
          <description>12.5 ug b.i.d.</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>b.i.d.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</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="6" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>CARDIOPULMONARY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>INGUINAL HERNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>PNEUMOPERITONEUM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HEPATIC FUNCTION ABNORMAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>EPIGLOTTITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>PERIRECTAL ABSCESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION BACTERIAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </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="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>GUN SHOT WOUND</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>HEPATIC ENZYME INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>BASAL CELL CARCINOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>HEPATIC CANCER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>METASTATIC MALIGNANT MELANOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>NON-SMALL CELL LUNG CANCER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>SQUAMOUS CELL CARCINOMA OF SKIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>HAEMOPTYSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>LUNG INFILTRATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSIVE CRISIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA</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="60" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="62" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="71" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>SEASONAL ALLERGY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION BACTERIAL</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="248"/>
              </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="4" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="36" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="248"/>
              </event>
              <event>
                <sub_title>SPUTUM INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="248"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="250"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="251"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="251"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="248"/>
              </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/NCT01712516
org study id: CQVA149A2337
nct id: NCT01712516
lead sponsor: 
has dmc: No
This study will assess the efficacy, safety and tolerability of indacaterol
      maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))
time frame: baseline (BL), 12 weeks
description: Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.
measure: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
time frame: BL, 12 Weeks
description: Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement.
measure: Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score
time frame: 12 weeks
description: Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.
measure: Change From Baseline in Trough FEV1
time frame: BL, day 2, day 86
description: Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.
measure: Change From Baseline in Pre-dose Trough FEV1
time frame: BL, day 85
description: Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.
measure: Change From Baseline in FEV1
time frame: BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min
description: Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
measure: Change From Baseline in FVC
time frame: BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min
description: Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
measure: Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)
time frame: BL, day 1, 12 weeks
description: Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.
measure: Transitional Dyspnea Index (TDI) Focal Score
time frame: BL, 12 weeks
description: The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.
measure: Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
time frame: BL, 12 weeks
description: Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.
measure: Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score
time frame: BL, 12 weeks
description: The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
arm group label: QVA149
arm group type: Experimental
description: 27.5/12.5 ug twice daily (b.i.d.) Single Dose Dry Powder Inhaler (SDDPI
arm group label: QAB149
arm group type: Active Comparator
description: 27.5 ug b.i.d.
arm group label: NVA237
arm group type: Active Comparator
description: 12.5 ug b.i.d.
arm group label: Placebo
arm group type: Placebo Comparator
description: b.i.d.
intervention type: Drug
intervention name: QVA149
description: QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
arm group label: QVA149
intervention type: Drug
intervention name: QAB149
description: QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
arm group label: QAB149
intervention type: Drug
intervention name: NVA237
description: NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
arm group label: NVA237
intervention type: Drug
intervention name: Placebo
description: Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Colombia
country: Egypt
country: France
country: Guatemala
country: Hungary
country: Panama
country: Slovakia
country: Slovenia
country: United States
country: Argentina
country: Mexico
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Glycopyrrolate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 