<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/NCT03257995</url>
  </required_header>
  <id_info>
    <org_study_id>CQVM149B2203</org_study_id>
    <nct_id>NCT03257995</nct_id>
  </id_info>
  <brief_title>Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Three-period Cross-over Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts (Maleate and Acetate) Delivered Via the Concept1 Inhalation Device in Patients With Asthma</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, double-blind, placebo-controlled, three-period cross-over study&#xD;
      in approximately 54 subjects with asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, three-period cross-over study in&#xD;
      asthma patients. The study will consist of a screening epoch, followed by a treatment epoch&#xD;
      which consists of three treatment periods, and will conclude with an end of study epoch.&#xD;
&#xD;
      Each subject will be assigned to 1 of 6 treatment sequences and will sequentially receive the&#xD;
      investigational products and placebo during the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">January 18, 2018</completion_date>
  <primary_completion_date type="Actual">January 17, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trough FEV1</measure>
    <time_frame>Day 14 of each of the three treatment periods</time_frame>
    <description>FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics AUC 0-24hours at Steady State</measure>
    <time_frame>Day 14 of each of the three treatment periods</time_frame>
    <description>AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Maximum Concentration (Cmax) at Steady State (ss)</measure>
    <time_frame>Day 14 of each of the three treatment periods</time_frame>
    <description>Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Maximal Plasma Concentration (Tmax) at Steady State</measure>
    <time_frame>Day 14 of each of the three treatment periods</time_frame>
    <description>Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State</measure>
    <time_frame>Day 14 of each of the three treatment periods</time_frame>
    <description>The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate</measure>
    <time_frame>Day 14</time_frame>
    <description>Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Peak FEV1 on Day 14</measure>
    <time_frame>Day 14 of each of the three treatment periods</time_frame>
    <description>The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints</measure>
    <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
    <description>Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1. Day 14, FEV1 was measured at 24hours post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Predicted Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1 (% Predicted) at All Timepoints</measure>
    <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
    <description>The FEV1 percent predicted expresses FEV1 as a percentage of the &quot;predicted values&quot; for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC)</measure>
    <time_frame>Day 14 of each of the three treatment periods at at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
    <description>Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted)</measure>
    <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
    <description>Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1/FVC</measure>
    <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
    <description>Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75%</measure>
    <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
    <description>The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC.</measure>
    <time_frame>Pre-dose to 4 hours post-dose on Day 14 of each of the three treatment periods</time_frame>
    <description>Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 μg and placebo, and between indacaterol acetate 150 μg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue Medication Usage</measure>
    <time_frame>14 days of treatment for each of the three treatment periods</time_frame>
    <description>The mean daily number of puffs of rescue medication usage as reported by subjects via diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Overall Peak Expiratory Flow (PEF)</measure>
    <time_frame>Days 8 through Day 14 of each of the three treatment periods</time_frame>
    <description>A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A-B-C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>B-C-A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>C-A-B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A-C-B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>B-A-C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>C-B-A</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indacaterol maleate</intervention_name>
    <description>150 μg via Concept1 device</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_label>Sequence 5</arm_group_label>
    <arm_group_label>Sequence 6</arm_group_label>
    <other_name>A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indacaterol acetate</intervention_name>
    <description>150 μg via Concept1 device</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_label>Sequence 5</arm_group_label>
    <arm_group_label>Sequence 6</arm_group_label>
    <other_name>B</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsule containing no active ingredients delivered via Concept1 device</description>
    <arm_group_label>Sequence 1</arm_group_label>
    <arm_group_label>Sequence 2</arm_group_label>
    <arm_group_label>Sequence 3</arm_group_label>
    <arm_group_label>Sequence 4</arm_group_label>
    <arm_group_label>Sequence 5</arm_group_label>
    <arm_group_label>Sequence 6</arm_group_label>
    <other_name>C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged ≥ 18 and above&#xD;
&#xD;
          -  Patients with a documented physician diagnosis of asthma for a period of at least 1&#xD;
             year prior to screening and who additionally meet the following criteria:&#xD;
&#xD;
        Patients receiving daily treatment with an inhaled corticosteroid up to the maximum dose&#xD;
        per day (as indicated in the package leaflet), on a stable regimen for at least 4 weeks&#xD;
        prior to screening.&#xD;
&#xD;
          -  Pre-bronchodilator FEV1 ≥ 50 % and ≤ 90% of the predicted normal value for the patient&#xD;
             during screening.&#xD;
&#xD;
          -  Patients who demonstrate an increase in FEV1 of ≥ 12% and ≥ 200 mL after&#xD;
             administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at&#xD;
             screening.&#xD;
&#xD;
          -  Subjects must weigh at least 50 kg at screening to participate in the study, and must&#xD;
             have a body mass index (BMI) within the range of 18 to 40 kg/m2.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
        -Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to&#xD;
        any of the following inhaled drugs, drugs of a similar class, or any component thereof:&#xD;
        Sympathomimetic amines / adrenoceptor agonist agents Lactose or any of the other excipients&#xD;
        of the study drug (including patients with history of galactose intolerance, Lapp lactase&#xD;
        deficiency or glucose-galactose malabsorption)&#xD;
&#xD;
          -  Patients who have had an asthma attack/exacerbation requiring systemic steroids or&#xD;
             hospitalization or emergency room visit within 6 weeks of screening.&#xD;
&#xD;
          -  Patients who have had a respiratory tract infection or asthma worsening within 4 weeks&#xD;
             prior to screening.&#xD;
&#xD;
          -  Patients with a history of chronic lung diseases other than asthma&#xD;
&#xD;
          -  Patients who have a decline in PEF from the reference PEF (taken at screening) of ≥30%&#xD;
             for 5 of 6 consecutive scheduled PEF readings (readings taken at morning and evening)&#xD;
             during at least 3 days of screening epoch prior to randomization.&#xD;
&#xD;
          -  Patients who require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours&#xD;
             (over two consecutive days) during screening prior to randomization.&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive hCG laboratory test.&#xD;
&#xD;
          -  Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c &gt; 9%) at&#xD;
             screening.&#xD;
&#xD;
          -  Current smokers (urine cotinine &gt; than the laboratory's lowest level of quantification&#xD;
             (LoQ of 500 ng/mL or lower)) and patients who have smoked or inhaled tobacco products&#xD;
             within the 6 month period prior to screening, or who have a smoking history of greater&#xD;
             than 10 pack years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1&#xD;
             pack /day x 10 yrs., or ½ pack/day x 20 yrs.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747-3322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <zip>08558</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>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=438</url>
    <description>A Plain Language Trial Summary is available on novartisclinicatrials.com</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>June 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>January 8, 2019</results_first_submitted>
  <results_first_submitted_qc>March 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 29, 2019</results_first_posted>
  <last_update_submitted>December 9, 2020</last_update_submitted>
  <last_update_submitted_qc>December 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma, asthma attack, difficulty breathing, bronchial diseases, lung, lung diseases, inhaled drugs, bronchodilator, inhaled corticosteriod</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maleic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03257995/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03257995/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sequence 1</title>
          <description>indacaterol maleate 150 μg , indacaterol acetate 150 μg and matching placebo</description>
        </group>
        <group group_id="P2">
          <title>Sequence 2</title>
          <description>indacaterol acetate 150 μg, matching placebo and indacaterol maleate 150 μg</description>
        </group>
        <group group_id="P3">
          <title>Sequence 3</title>
          <description>Placebo, indacaterol maleate 150 μg and indacaterol acetate 150 μg</description>
        </group>
        <group group_id="P4">
          <title>Sequence 4</title>
          <description>indacaterol maleate 150 μg, placebo, and indacaterol acetate 150 μg</description>
        </group>
        <group group_id="P5">
          <title>Sequence 5</title>
          <description>indacaterol acetate 150 μg, indacaterol maleate 150 μg, and placebo</description>
        </group>
        <group group_id="P6">
          <title>Sequence 6</title>
          <description>Placebo, indacaterol acetate 150 μg, indacaterol maleate 150 μg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</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 group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All participants randomized to one of six treatment sequences</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.7" spread="12.5"/>
                  </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="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Trough FEV1</title>
        <description>FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate</description>
        <time_frame>Day 14 of each of the three treatment periods</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Trough FEV1</title>
          <description>FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4173" spread="0.78214"/>
                    <measurement group_id="O2" value="2.3774" spread="0.77679"/>
                    <measurement group_id="O3" value="2.2191" spread="0.72350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1861</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1293</ci_lower_limit>
            <ci_upper_limit>0.2429</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1463</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0898</ci_lower_limit>
            <ci_upper_limit>0.2029</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0398</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0942</ci_lower_limit>
            <ci_upper_limit>0.0147</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics AUC 0-24hours at Steady State</title>
        <description>AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings</description>
        <time_frame>Day 14 of each of the three treatment periods</time_frame>
        <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics AUC 0-24hours at Steady State</title>
          <description>AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings</description>
          <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
          <units>h*pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2300" spread="732"/>
                    <measurement group_id="O2" value="2050" spread="636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Maximum Concentration (Cmax) at Steady State (ss)</title>
        <description>Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings.</description>
        <time_frame>Day 14 of each of the three treatment periods</time_frame>
        <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>The Maximum Concentration (Cmax) at Steady State (ss)</title>
          <description>Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings.</description>
          <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="249" lower_limit="126" upper_limit="443"/>
                    <measurement group_id="O2" value="224" lower_limit="84.9" upper_limit="426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Maximal Plasma Concentration (Tmax) at Steady State</title>
        <description>Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14</description>
        <time_frame>Day 14 of each of the three treatment periods</time_frame>
        <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximal Plasma Concentration (Tmax) at Steady State</title>
          <description>Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14</description>
          <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.250" lower_limit="0.183" upper_limit="0.850"/>
                    <measurement group_id="O2" value="0.467" lower_limit="0.183" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State</title>
        <description>The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided.</description>
        <time_frame>Day 14 of each of the three treatment periods</time_frame>
        <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State</title>
          <description>The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided.</description>
          <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.</population>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" lower_limit="14.5" upper_limit="126"/>
                    <measurement group_id="O2" value="52.3" lower_limit="9.03" upper_limit="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate</title>
        <description>Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate.</description>
        <time_frame>Day 14</time_frame>
        <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data. Only summary statistics for relative bioavailability was provided.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate / Indacaterol Acetate</title>
            <description>Relative bioavailability of indacaterol acetate compared to indacaterol maleate (Frel) AUC0-24h,ss</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>Relative bioavailability of indacaterol acetate compared to indacaterol maleate (Frel) Cmax,ss</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate</title>
          <description>Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate.</description>
          <population>The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data. Only summary statistics for relative bioavailability was provided.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.912" spread="0.201"/>
                    <measurement group_id="O2" value="0.910" spread="0.242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Peak FEV1 on Day 14</title>
        <description>The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo</description>
        <time_frame>Day 14 of each of the three treatment periods</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Peak FEV1 on Day 14</title>
          <description>The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>h</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" lower_limit="-0.83" upper_limit="0.33"/>
                    <measurement group_id="O2" value="-0.02" lower_limit="-0.82" upper_limit="0.51"/>
                    <measurement group_id="O3" value="0.00" lower_limit="-0.50" upper_limit="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.823</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.801</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.82</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.984</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.50</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints</title>
        <description>Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1. Day 14, FEV1 was measured at 24hours post dose</description>
        <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints</title>
          <description>Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1. Day 14, FEV1 was measured at 24hours post dose</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4795" lower_limit="2.2575" upper_limit="2.7014"/>
                    <measurement group_id="O2" value="2.4813" lower_limit="2.2595" upper_limit="2.7031"/>
                    <measurement group_id="O3" value="2.2617" lower_limit="2.0398" upper_limit="2.4837"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5005" lower_limit="2.2786" upper_limit="2.7224"/>
                    <measurement group_id="O2" value="2.4965" lower_limit="2.2746" upper_limit="2.7184"/>
                    <measurement group_id="O3" value="2.2282" lower_limit="2.0062" upper_limit="2.4501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5204" lower_limit="2.2985" upper_limit="2.7424"/>
                    <measurement group_id="O2" value="2.5047" lower_limit="2.2829" upper_limit="2.7265"/>
                    <measurement group_id="O3" value="2.2475" lower_limit="2.0255" upper_limit="2.4694"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5279" lower_limit="2.3060" upper_limit="2.7498"/>
                    <measurement group_id="O2" value="2.5018" lower_limit="2.2800" upper_limit="2.7236"/>
                    <measurement group_id="O3" value="2.2670" lower_limit="2.0451" upper_limit="2.4889"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5286" lower_limit="2.3067" upper_limit="2.7505"/>
                    <measurement group_id="O2" value="2.5338" lower_limit="2.3120" upper_limit="2.7556"/>
                    <measurement group_id="O3" value="2.2792" lower_limit="2.0573" upper_limit="2.5011"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5054" lower_limit="2.2835" upper_limit="2.7273"/>
                    <measurement group_id="O2" value="2.5103" lower_limit="2.2885" upper_limit="2.7321"/>
                    <measurement group_id="O3" value="2.2781" lower_limit="2.0561" upper_limit="2.5001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4668" lower_limit="2.2448" upper_limit="2.6888"/>
                    <measurement group_id="O2" value="2.4596" lower_limit="2.2378" upper_limit="2.6814"/>
                    <measurement group_id="O3" value="2.2272" lower_limit="2.0052" upper_limit="2.4492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4222" lower_limit="2.2002" upper_limit="2.6442"/>
                    <measurement group_id="O2" value="2.3836" lower_limit="2.1618" upper_limit="2.6054"/>
                    <measurement group_id="O3" value="2.1779" lower_limit="1.9558" upper_limit="2.3999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4678" lower_limit="2.2457" upper_limit="2.6899"/>
                    <measurement group_id="O2" value="2.4022" lower_limit="2.1804" upper_limit="2.6241"/>
                    <measurement group_id="O3" value="2.2398" lower_limit="2.0173" upper_limit="2.4622"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 45 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4585" lower_limit="2.2364" upper_limit="2.6806"/>
                    <measurement group_id="O2" value="2.4424" lower_limit="2.2205" upper_limit="2.6642"/>
                    <measurement group_id="O3" value="2.2631" lower_limit="2.0407" upper_limit="2.4856"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2177</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1482</ci_lower_limit>
            <ci_upper_limit>0.2872</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2724</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2030</ci_lower_limit>
            <ci_upper_limit>0.3417</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2730</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2036</ci_lower_limit>
            <ci_upper_limit>0.3423</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2609</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1915</ci_lower_limit>
            <ci_upper_limit>0.3302</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2494</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1800</ci_lower_limit>
            <ci_upper_limit>0.3188</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2273</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1578</ci_lower_limit>
            <ci_upper_limit>0.2968</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2396</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1697</ci_lower_limit>
            <ci_upper_limit>0.3096</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2443</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1742</ci_lower_limit>
            <ci_upper_limit>0.3144</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2280</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1563</ci_lower_limit>
            <ci_upper_limit>0.2997</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1954</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1237</ci_lower_limit>
            <ci_upper_limit>0.2671</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2195</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1502</ci_lower_limit>
            <ci_upper_limit>0.2889</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2684</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1988</ci_lower_limit>
            <ci_upper_limit>0.3380</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2572</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1879</ci_lower_limit>
            <ci_upper_limit>0.3266</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2348</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1656</ci_lower_limit>
            <ci_upper_limit>0.3040</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2546</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1852</ci_lower_limit>
            <ci_upper_limit>0.3239</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2322</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1627</ci_lower_limit>
            <ci_upper_limit>0.3017</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2324</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1627</ci_lower_limit>
            <ci_upper_limit>0.3020</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2057</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1359</ci_lower_limit>
            <ci_upper_limit>0.2755</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1625</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0912</ci_lower_limit>
            <ci_upper_limit>0.2337</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1793</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1080</ci_lower_limit>
            <ci_upper_limit>0.2505</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Predicted Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1 (% Predicted) at All Timepoints</title>
        <description>The FEV1 percent predicted expresses FEV1 as a percentage of the &quot;predicted values&quot; for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days</description>
        <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Predicted Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1 (% Predicted) at All Timepoints</title>
          <description>The FEV1 percent predicted expresses FEV1 as a percentage of the &quot;predicted values&quot; for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>Percent of predicted</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.2" lower_limit="74.7" upper_limit="81.7"/>
                    <measurement group_id="O2" value="78.2" lower_limit="74.8" upper_limit="81.7"/>
                    <measurement group_id="O3" value="71.1" lower_limit="67.7" upper_limit="74.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.7" lower_limit="75.2" upper_limit="82.2"/>
                    <measurement group_id="O2" value="78.5" lower_limit="75.0" upper_limit="82.0"/>
                    <measurement group_id="O3" value="70.2" lower_limit="66.7" upper_limit="73.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4" lower_limit="75.9" upper_limit="82.9"/>
                    <measurement group_id="O2" value="78.9" lower_limit="75.4" upper_limit="82.3"/>
                    <measurement group_id="O3" value="70.7" lower_limit="67.3" upper_limit="74.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.5" lower_limit="76.0" upper_limit="83.0"/>
                    <measurement group_id="O2" value="78.8" lower_limit="75.3" upper_limit="82.3"/>
                    <measurement group_id="O3" value="71.4" lower_limit="67.9" upper_limit="74.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.6" lower_limit="76.1" upper_limit="83.1"/>
                    <measurement group_id="O2" value="79.8" lower_limit="76.3" upper_limit="83.2"/>
                    <measurement group_id="O3" value="72.0" lower_limit="68.5" upper_limit="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.8" lower_limit="75.4" upper_limit="82.3"/>
                    <measurement group_id="O2" value="79.1" lower_limit="75.6" upper_limit="82.5"/>
                    <measurement group_id="O3" value="71.8" lower_limit="68.3" upper_limit="75.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5" lower_limit="74.0" upper_limit="81.0"/>
                    <measurement group_id="O2" value="77.5" lower_limit="74.1" upper_limit="81.0"/>
                    <measurement group_id="O3" value="70.2" lower_limit="66.7" upper_limit="73.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.2" lower_limit="72.7" upper_limit="79.7"/>
                    <measurement group_id="O2" value="75.0" lower_limit="71.5" upper_limit="78.5"/>
                    <measurement group_id="O3" value="68.6" lower_limit="65.2" upper_limit="72.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hours 15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.9" lower_limit="74.5" upper_limit="81.4"/>
                    <measurement group_id="O2" value="76.1" lower_limit="72.6" upper_limit="79.5"/>
                    <measurement group_id="O3" value="71.0" lower_limit="67.5" upper_limit="74.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hours 45 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" lower_limit="74.3" upper_limit="81.3"/>
                    <measurement group_id="O2" value="77.2" lower_limit="73.7" upper_limit="80.7"/>
                    <measurement group_id="O3" value="71.4" lower_limit="67.8" upper_limit="74.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.0</ci_lower_limit>
            <ci_upper_limit>9.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.4</ci_lower_limit>
            <ci_upper_limit>10.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 30</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.5</ci_lower_limit>
            <ci_upper_limit>10.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.0</ci_lower_limit>
            <ci_upper_limit>10.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 2 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.5</ci_lower_limit>
            <ci_upper_limit>9.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 4 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.0</ci_lower_limit>
            <ci_upper_limit>9.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 8 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.2</ci_lower_limit>
            <ci_upper_limit>9.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 12 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.5</ci_lower_limit>
            <ci_upper_limit>9.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 23 hours 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.8</ci_lower_limit>
            <ci_upper_limit>9.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 23 hours 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.2</ci_lower_limit>
            <ci_upper_limit>8.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.0</ci_lower_limit>
            <ci_upper_limit>9.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.2</ci_lower_limit>
            <ci_upper_limit>10.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.0</ci_lower_limit>
            <ci_upper_limit>10.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>9.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 2 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.7</ci_lower_limit>
            <ci_upper_limit>9.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 4 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.2</ci_lower_limit>
            <ci_upper_limit>9.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 8 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>9.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 12 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.2</ci_lower_limit>
            <ci_upper_limit>8.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 23 hours 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.9</ci_lower_limit>
            <ci_upper_limit>7.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>at 23 hours 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.7</ci_lower_limit>
            <ci_upper_limit>8.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC)</title>
        <description>Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.</description>
        <time_frame>Day 14 of each of the three treatment periods at at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC)</title>
          <description>Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>liter</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5648" lower_limit="3.2407" upper_limit="3.8890"/>
                    <measurement group_id="O2" value="3.5912" lower_limit="3.2672" upper_limit="3.9152"/>
                    <measurement group_id="O3" value="3.3783" lower_limit="3.0541" upper_limit="3.7024"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5850" lower_limit="3.2608" upper_limit="3.9091"/>
                    <measurement group_id="O2" value="3.5773" lower_limit="3.2531" upper_limit="3.9015"/>
                    <measurement group_id="O3" value="3.3600" lower_limit="3.0359" upper_limit="3.6842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6068" lower_limit="3.2827" upper_limit="3.9310"/>
                    <measurement group_id="O2" value="3.6039" lower_limit="3.2798" upper_limit="3.9279"/>
                    <measurement group_id="O3" value="3.3664" lower_limit="3.0422" upper_limit="3.6905"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5946" lower_limit="3.2705" upper_limit="3.9188"/>
                    <measurement group_id="O2" value="3.5886" lower_limit="3.2645" upper_limit="3.9126"/>
                    <measurement group_id="O3" value="3.3873" lower_limit="3.0631" upper_limit="3.7114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5789" lower_limit="3.2548" upper_limit="3.9031"/>
                    <measurement group_id="O2" value="3.5992" lower_limit="3.2751" upper_limit="3.9233"/>
                    <measurement group_id="O3" value="3.3987" lower_limit="3.0745" upper_limit="3.7228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5674" lower_limit="3.2433" upper_limit="3.8916"/>
                    <measurement group_id="O2" value="3.5999" lower_limit="3.2759" upper_limit="3.9240"/>
                    <measurement group_id="O3" value="3.4053" lower_limit="3.0812" upper_limit="3.7295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5670" lower_limit="3.2428" upper_limit="3.8913"/>
                    <measurement group_id="O2" value="3.5617" lower_limit="3.2376" upper_limit="3.8858"/>
                    <measurement group_id="O3" value="3.3680" lower_limit="3.0438" upper_limit="3.6922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4941" lower_limit="3.1698" upper_limit="3.8183"/>
                    <measurement group_id="O2" value="3.4812" lower_limit="3.1571" upper_limit="3.8053"/>
                    <measurement group_id="O3" value="3.3193" lower_limit="2.9950" upper_limit="3.6436"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6055" lower_limit="3.2812" upper_limit="3.9298"/>
                    <measurement group_id="O2" value="3.5448" lower_limit="3.2207" upper_limit="3.8689"/>
                    <measurement group_id="O3" value="3.4199" lower_limit="3.0952" upper_limit="3.7446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 45 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5668" lower_limit="3.2425" upper_limit="3.8912"/>
                    <measurement group_id="O2" value="3.5731" lower_limit="3.2489" upper_limit="3.8972"/>
                    <measurement group_id="O3" value="3.4185" lower_limit="3.0938" upper_limit="3.7431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1866</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1121</ci_lower_limit>
            <ci_upper_limit>0.2611</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2249</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1506</ci_lower_limit>
            <ci_upper_limit>0.2992</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2404</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1661</ci_lower_limit>
            <ci_upper_limit>0.3148</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2074</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1330</ci_lower_limit>
            <ci_upper_limit>0.2817</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1802</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1059</ci_lower_limit>
            <ci_upper_limit>0.2545</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1621</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0876</ci_lower_limit>
            <ci_upper_limit>0.2366</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1990</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1239</ci_lower_limit>
            <ci_upper_limit>0.2742</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1747</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0994</ci_lower_limit>
            <ci_upper_limit>0.2501</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hours 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1856</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1081</ci_lower_limit>
            <ci_upper_limit>0.2631</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hours 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1484</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0709</ci_lower_limit>
            <ci_upper_limit>0.2259</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2130</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1386</ci_lower_limit>
            <ci_upper_limit>0.2873</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2173</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1426</ci_lower_limit>
            <ci_upper_limit>0.2920</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2375</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1632</ci_lower_limit>
            <ci_upper_limit>0.3118</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2013</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1272</ci_lower_limit>
            <ci_upper_limit>0.2754</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2005</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1262</ci_lower_limit>
            <ci_upper_limit>0.2749</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1946</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1201</ci_lower_limit>
            <ci_upper_limit>0.2691</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1937</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1190</ci_lower_limit>
            <ci_upper_limit>0.2684</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1619</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0870</ci_lower_limit>
            <ci_upper_limit>0.2369</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1249</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0480</ci_lower_limit>
            <ci_upper_limit>0.2018</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1546</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0777</ci_lower_limit>
            <ci_upper_limit>0.2315</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted)</title>
        <description>Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.</description>
        <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted)</title>
          <description>Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>Percentage of predicted FVC</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4" lower_limit="86.1" upper_limit="94.6"/>
                    <measurement group_id="O2" value="91.2" lower_limit="86.9" upper_limit="95.4"/>
                    <measurement group_id="O3" value="85.3" lower_limit="81.1" upper_limit="89.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" lower_limit="86.6" upper_limit="95.1"/>
                    <measurement group_id="O2" value="90.7" lower_limit="86.5" upper_limit="95.0"/>
                    <measurement group_id="O3" value="84.9" lower_limit="80.6" upper_limit="89.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.6" lower_limit="87.4" upper_limit="95.9"/>
                    <measurement group_id="O2" value="91.4" lower_limit="87.2" upper_limit="95.7"/>
                    <measurement group_id="O3" value="85.1" lower_limit="80.8" upper_limit="89.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.1" lower_limit="86.8" upper_limit="95.3"/>
                    <measurement group_id="O2" value="91.1" lower_limit="86.9" upper_limit="95.3"/>
                    <measurement group_id="O3" value="85.6" lower_limit="81.4" upper_limit="89.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.7" lower_limit="86.4" upper_limit="94.9"/>
                    <measurement group_id="O2" value="91.4" lower_limit="87.1" upper_limit="95.6"/>
                    <measurement group_id="O3" value="85.9" lower_limit="81.7" upper_limit="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" lower_limit="86.3" upper_limit="94.8"/>
                    <measurement group_id="O2" value="91.3" lower_limit="87.0" upper_limit="95.5"/>
                    <measurement group_id="O3" value="86.2" lower_limit="82.0" upper_limit="90.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4" lower_limit="86.1" upper_limit="94.6"/>
                    <measurement group_id="O2" value="90.3" lower_limit="86.1" upper_limit="94.6"/>
                    <measurement group_id="O3" value="85.4" lower_limit="81.1" upper_limit="89.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5" lower_limit="84.3" upper_limit="92.8"/>
                    <measurement group_id="O2" value="88.2" lower_limit="84.0" upper_limit="92.5"/>
                    <measurement group_id="O3" value="84" lower_limit="79.8" upper_limit="88.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hours 15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.5" lower_limit="87.2" upper_limit="95.7"/>
                    <measurement group_id="O2" value="89.9" lower_limit="85.6" upper_limit="94.1"/>
                    <measurement group_id="O3" value="86.9" lower_limit="82.6" upper_limit="91.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hours 45 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6" lower_limit="86.4" upper_limit="94.9"/>
                    <measurement group_id="O2" value="90.6" lower_limit="86.4" upper_limit="94.9"/>
                    <measurement group_id="O3" value="86.5" lower_limit="82.3" upper_limit="90.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.1</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4</ci_lower_limit>
            <ci_upper_limit>7.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.6</ci_lower_limit>
            <ci_upper_limit>8.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.5</ci_lower_limit>
            <ci_upper_limit>7.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.8</ci_lower_limit>
            <ci_upper_limit>6.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.3</ci_lower_limit>
            <ci_upper_limit>6.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3</ci_lower_limit>
            <ci_upper_limit>7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.5</ci_lower_limit>
            <ci_upper_limit>6.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>23 hour 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.6</ci_lower_limit>
            <ci_upper_limit>6.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.0</ci_lower_limit>
            <ci_upper_limit>6.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.9</ci_lower_limit>
            <ci_upper_limit>7.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.9</ci_lower_limit>
            <ci_upper_limit>7.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.4</ci_lower_limit>
            <ci_upper_limit>8.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.5</ci_lower_limit>
            <ci_upper_limit>7.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.5</ci_lower_limit>
            <ci_upper_limit>7.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.1</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.0</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.2</ci_lower_limit>
            <ci_upper_limit>6.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0</ci_lower_limit>
            <ci_upper_limit>5.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.1</ci_lower_limit>
            <ci_upper_limit>6.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1/FVC</title>
        <description>Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.</description>
        <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1/FVC</title>
          <description>Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>Ratio</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6979" lower_limit="0.6728" upper_limit="0.7230"/>
                    <measurement group_id="O2" value="0.6952" lower_limit="0.6701" upper_limit="0.7202"/>
                    <measurement group_id="O3" value="0.6729" lower_limit="0.6478" upper_limit="0.6981"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7002" lower_limit="0.6751" upper_limit="0.7253"/>
                    <measurement group_id="O2" value="0.7017" lower_limit="0.6766" upper_limit="0.7268"/>
                    <measurement group_id="O3" value="0.6672" lower_limit="0.6421" upper_limit="0.6923"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7012" lower_limit="0.6761" upper_limit="0.7263"/>
                    <measurement group_id="O2" value="0.6996" lower_limit="0.6745" upper_limit="0.7246"/>
                    <measurement group_id="O3" value="0.6706" lower_limit="0.6455" upper_limit="0.6957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7053" lower_limit="0.6802" upper_limit="0.7304"/>
                    <measurement group_id="O2" value="0.7007" lower_limit="0.6757" upper_limit="0.7258"/>
                    <measurement group_id="O3" value="0.6729" lower_limit="0.6478" upper_limit="0.6980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7085" lower_limit="0.6834" upper_limit="0.7336"/>
                    <measurement group_id="O2" value="0.7085" lower_limit="0.6834" upper_limit="0.7335"/>
                    <measurement group_id="O3" value="0.6747" lower_limit="0.6496" upper_limit="0.6998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7057" lower_limit="0.6806" upper_limit="0.7308"/>
                    <measurement group_id="O2" value="0.7010" lower_limit="0.6759" upper_limit="0.7261"/>
                    <measurement group_id="O3" value="0.6732" lower_limit="0.6481" upper_limit="0.6984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6962" lower_limit="0.6710" upper_limit="0.7213"/>
                    <measurement group_id="O2" value="0.6967" lower_limit="0.6716" upper_limit="0.7218"/>
                    <measurement group_id="O3" value="0.6651" lower_limit="0.6399" upper_limit="0.6902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6958" lower_limit="0.6707" upper_limit="0.7210"/>
                    <measurement group_id="O2" value="0.6885" lower_limit="0.6634" upper_limit="0.7135"/>
                    <measurement group_id="O3" value="0.6599" lower_limit="0.6348" upper_limit="0.6851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6898" lower_limit="0.6647" upper_limit="0.7150"/>
                    <measurement group_id="O2" value="0.6853" lower_limit="0.6602" upper_limit="0.7104"/>
                    <measurement group_id="O3" value="0.6572" lower_limit="0.6320" upper_limit="0.6825"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 45 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6934" lower_limit="0.6683" upper_limit="0.7186"/>
                    <measurement group_id="O2" value="0.6899" lower_limit="0.6648" upper_limit="0.7150"/>
                    <measurement group_id="O3" value="0.6633" lower_limit="0.6381" upper_limit="0.6886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0249</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0139</ci_lower_limit>
            <ci_upper_limit>0.0359</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0330</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0220</ci_lower_limit>
            <ci_upper_limit>0.0440</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0306</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0197</ci_lower_limit>
            <ci_upper_limit>0.0416</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0324</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0214</ci_lower_limit>
            <ci_upper_limit>0.0434</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0338</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0228</ci_lower_limit>
            <ci_upper_limit>0.0447</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0325</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0215</ci_lower_limit>
            <ci_upper_limit>0.0435</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0311</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0200</ci_lower_limit>
            <ci_upper_limit>0.0422</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0359</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0248</ci_lower_limit>
            <ci_upper_limit>0.0470</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0326</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0211</ci_lower_limit>
            <ci_upper_limit>0.0440</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0301</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0187</ci_lower_limit>
            <ci_upper_limit>0.0415</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0222</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0113</ci_lower_limit>
            <ci_upper_limit>0.0332</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0344</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0234</ci_lower_limit>
            <ci_upper_limit>0.0454</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0290</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0180</ci_lower_limit>
            <ci_upper_limit>0.0399</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0278</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0169</ci_lower_limit>
            <ci_upper_limit>0.0387</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0338</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0228</ci_lower_limit>
            <ci_upper_limit>0.0447</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0278</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0168</ci_lower_limit>
            <ci_upper_limit>0.0387</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0316</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0206</ci_lower_limit>
            <ci_upper_limit>0.0426</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0285</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0175</ci_lower_limit>
            <ci_upper_limit>0.0396</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0281</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0167</ci_lower_limit>
            <ci_upper_limit>0.0394</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hour 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.0266</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0152</ci_lower_limit>
            <ci_upper_limit>0.0379</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75%</title>
        <description>The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days</description>
        <time_frame>Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75%</title>
          <description>The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>Liters/second</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6968" lower_limit="1.4675" upper_limit="1.9261"/>
                    <measurement group_id="O2" value="1.6918" lower_limit="1.4628" upper_limit="1.9208"/>
                    <measurement group_id="O3" value="1.4962" lower_limit="1.2668" upper_limit="1.7256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7454" lower_limit="1.5160" upper_limit="1.9747"/>
                    <measurement group_id="O2" value="1.7458" lower_limit="1.5165" upper_limit="1.9751"/>
                    <measurement group_id="O3" value="1.4531" lower_limit="1.2238" upper_limit="1.6824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7347" lower_limit="1.5053" upper_limit="1.9640"/>
                    <measurement group_id="O2" value="1.7413" lower_limit="1.5122" upper_limit="1.9704"/>
                    <measurement group_id="O3" value="1.4690" lower_limit="1.2397" upper_limit="1.6983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="52"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7715" lower_limit="1.5422" upper_limit="2.0008"/>
                    <measurement group_id="O2" value="1.7349" lower_limit="1.5059" upper_limit="1.9640"/>
                    <measurement group_id="O3" value="1.4963" lower_limit="1.2670" upper_limit="1.7256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7907" lower_limit="1.5613" upper_limit="2.0200"/>
                    <measurement group_id="O2" value="1.8074" lower_limit="1.5782" upper_limit="2.0365"/>
                    <measurement group_id="O3" value="1.5088" lower_limit="1.2795" upper_limit="1.7381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7663" lower_limit="1.5370" upper_limit="1.9956"/>
                    <measurement group_id="O2" value="1.7503" lower_limit="1.5212" upper_limit="1.9795"/>
                    <measurement group_id="O3" value="1.4843" lower_limit="1.2549" upper_limit="1.7137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6755" lower_limit="1.4460" upper_limit="1.9050"/>
                    <measurement group_id="O2" value="1.6774" lower_limit="1.4483" upper_limit="1.9066"/>
                    <measurement group_id="O3" value="1.4217" lower_limit="1.1922" upper_limit="1.6512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6549" lower_limit="1.4254" upper_limit="1.8844"/>
                    <measurement group_id="O2" value="1.5849" lower_limit="1.3557" upper_limit="1.8140"/>
                    <measurement group_id="O3" value="1.3862" lower_limit="1.1566" upper_limit="1.6158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 15 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6667" lower_limit="1.4370" upper_limit="1.8964"/>
                    <measurement group_id="O2" value="1.6257" lower_limit="1.3965" upper_limit="1.8550"/>
                    <measurement group_id="O3" value="1.4214" lower_limit="1.1910" upper_limit="1.6518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23 hour 45 min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6446" lower_limit="1.4149" upper_limit="1.8743"/>
                    <measurement group_id="O2" value="1.6580" lower_limit="1.4288" upper_limit="1.8873"/>
                    <measurement group_id="O3" value="1.4584" lower_limit="1.2280" upper_limit="1.6866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2025</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1059</ci_lower_limit>
            <ci_upper_limit>0.2952</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2923</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1979</ci_lower_limit>
            <ci_upper_limit>0.3867</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2657</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1713</ci_lower_limit>
            <ci_upper_limit>0.3601</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2752</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1808</ci_lower_limit>
            <ci_upper_limit>0.3696</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2819</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1875</ci_lower_limit>
            <ci_upper_limit>0.3763</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2820</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1874</ci_lower_limit>
            <ci_upper_limit>0.3766</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2538</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1585</ci_lower_limit>
            <ci_upper_limit>0.3492</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2687</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1732</ci_lower_limit>
            <ci_upper_limit>0.3643</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hours 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2453</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1473</ci_lower_limit>
            <ci_upper_limit>0.3434</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hours 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1862</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0882</ci_lower_limit>
            <ci_upper_limit>0.2842</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>5 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1956</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1012</ci_lower_limit>
            <ci_upper_limit>0.2899</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2927</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1979</ci_lower_limit>
            <ci_upper_limit>0.3875</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>30 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2723</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1780</ci_lower_limit>
            <ci_upper_limit>0.3667</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>1 hour</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2386</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1445</ci_lower_limit>
            <ci_upper_limit>0.3328</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>2 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2986</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2042</ci_lower_limit>
            <ci_upper_limit>0.3930</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2661</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1715</ci_lower_limit>
            <ci_upper_limit>0.3607</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>8 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2558</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1609</ci_lower_limit>
            <ci_upper_limit>0.3506</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>12 hours</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1987</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1036</ci_lower_limit>
            <ci_upper_limit>0.2938</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hours 15 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2044</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1071</ci_lower_limit>
            <ci_upper_limit>0.3017</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>23 hours 45 min</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.1997</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1023</ci_lower_limit>
            <ci_upper_limit>0.2970</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC.</title>
        <description>Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 μg and placebo, and between indacaterol acetate 150 μg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h)</description>
        <time_frame>Pre-dose to 4 hours post-dose on Day 14 of each of the three treatment periods</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC.</title>
          <description>Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 μg and placebo, and between indacaterol acetate 150 μg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h)</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</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="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5179" spread="0.11213"/>
                    <measurement group_id="O2" value="2.5151" spread="0.11205"/>
                    <measurement group_id="O3" value="2.2703" spread="0.11213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2476</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1857</ci_lower_limit>
            <ci_upper_limit>0.3095</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.2448</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1830</ci_lower_limit>
            <ci_upper_limit>0.3066</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.0028</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0647</ci_lower_limit>
            <ci_upper_limit>0.0590</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rescue Medication Usage</title>
        <description>The mean daily number of puffs of rescue medication usage as reported by subjects via diary.</description>
        <time_frame>14 days of treatment for each of the three treatment periods</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Rescue Medication Usage</title>
          <description>The mean daily number of puffs of rescue medication usage as reported by subjects via diary.</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>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="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="0.228"/>
                    <measurement group_id="O2" value="1.01" spread="0.227"/>
                    <measurement group_id="O3" value="1.43" spread="0.228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.73</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.73</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Overall Peak Expiratory Flow (PEF)</title>
        <description>A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates</description>
        <time_frame>Days 8 through Day 14 of each of the three treatment periods</time_frame>
        <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol Maleate 150 µg</title>
            <description>indacaterol maleate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol Acetate 150 µg</title>
            <description>indacaterol acetate 150 μg via Breezhaler</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>matching placebo capsules to indacaterol via Breezhaler</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Overall Peak Expiratory Flow (PEF)</title>
          <description>A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates</description>
          <population>The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data</population>
          <units>Liters/min</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="51"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="409.7" spread="15.06"/>
                    <measurement group_id="O2" value="407.6" spread="15.05"/>
                    <measurement group_id="O3" value="376.8" spread="15.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>33.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.6</ci_lower_limit>
            <ci_upper_limit>40.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>30.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.5</ci_lower_limit>
            <ci_upper_limit>38.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>until 30 days after the last Investigational Product (IP) administration</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Indacaterol Maleate 150 µg</title>
          <description>indacaterol maleate 150 μg via Breezhaler</description>
        </group>
        <group group_id="E2">
          <title>Indacaterol Acetate 150 µg</title>
          <description>indacaterol acetate 150 μg via Breezhaler</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>matching placebo capsules to indacaterol via Breezhaler</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (20.1)</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="14" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="53"/>
              </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>
      <email>novartis.email@novartis.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257995
org study id: CQVM149B2203
nct id: NCT03257995
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is a randomized, double-blind, placebo-controlled, three-period cross-over study
      in approximately 54 subjects with asthma.
This is a randomized, double-blind, placebo-controlled, three-period cross-over study in
      asthma patients. The study will consist of a screening epoch, followed by a treatment epoch
      which consists of three treatment periods, and will conclude with an end of study epoch.

      Each subject will be assigned to 1 of 6 treatment sequences and will sequentially receive the
      investigational products and placebo during the trial.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Trough FEV1
time frame: Day 14 of each of the three treatment periods
description: FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate
measure: Pharmacokinetics AUC 0-24hours at Steady State
time frame: Day 14 of each of the three treatment periods
description: AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings
measure: The Maximum Concentration (Cmax) at Steady State (ss)
time frame: Day 14 of each of the three treatment periods
description: Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings.
measure: Time of Maximal Plasma Concentration (Tmax) at Steady State
time frame: Day 14 of each of the three treatment periods
description: Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14
measure: The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State
time frame: Day 14 of each of the three treatment periods
description: The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided.
measure: Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate
time frame: Day 14
description: Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate.
measure: Time to Peak FEV1 on Day 14
time frame: Day 14 of each of the three treatment periods
description: The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo
measure: Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints
time frame: Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min
description: Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1. Day 14, FEV1 was measured at 24hours post dose
measure: Percent of Predicted Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1 (% Predicted) at All Timepoints
time frame: Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min
description: The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days
measure: Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC)
time frame: Day 14 of each of the three treatment periods at at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min
description: Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.
measure: Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted)
time frame: Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min
description: Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.
measure: Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1/FVC
time frame: Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min
description: Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.
measure: Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75%
time frame: Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min
description: The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days
measure: Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC.
time frame: Pre-dose to 4 hours post-dose on Day 14 of each of the three treatment periods
description: Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 μg and placebo, and between indacaterol acetate 150 μg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h)
measure: Rescue Medication Usage
time frame: 14 days of treatment for each of the three treatment periods
description: The mean daily number of puffs of rescue medication usage as reported by subjects via diary.
measure: Mean Overall Peak Expiratory Flow (PEF)
time frame: Days 8 through Day 14 of each of the three treatment periods
description: A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates
arm group label: Sequence 1
arm group type: Experimental
description: A-B-C
arm group label: Sequence 2
arm group type: Experimental
description: B-C-A
arm group label: Sequence 3
arm group type: Experimental
description: C-A-B
arm group label: Sequence 4
arm group type: Experimental
description: A-C-B
arm group label: Sequence 5
arm group type: Experimental
description: B-A-C
arm group label: Sequence 6
arm group type: Experimental
description: C-B-A
intervention type: Drug
intervention name: Indacaterol maleate
description: 150 μg via Concept1 device
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
arm group label: Sequence 5
arm group label: Sequence 6
other name: A
intervention type: Drug
intervention name: Indacaterol acetate
description: 150 μg via Concept1 device
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
arm group label: Sequence 5
arm group label: Sequence 6
other name: B
intervention type: Drug
intervention name: Placebo
description: Capsule containing no active ingredients delivered via Concept1 device
arm group label: Sequence 1
arm group label: Sequence 2
arm group label: Sequence 3
arm group label: Sequence 4
arm group label: Sequence 5
arm group label: Sequence 6
other name: C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=438
description: A Plain Language Trial Summary is available on novartisclinicatrials.com
responsible party type: Sponsor
mesh term: Asthma
mesh term: Maleic acid
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 