<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/NCT01727024</url>
  </required_header>
  <id_info>
    <org_study_id>CQAB149BBR02</org_study_id>
    <nct_id>NCT01727024</nct_id>
  </id_info>
  <brief_title>Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients</brief_title>
  <acronym>INHALATOR</acronym>
  <official_title>Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <brief_summary>
    <textblock>
      This study compared the correct use of and patient preference for two drug delivery systems&#xD;
      (inhalers) in patients with COPD&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Correctly Used the Device at the Start of Handling the Device</measure>
    <time_frame>day 1</time_frame>
    <description>The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Correctly Using the Device After One Week of Handling</measure>
    <time_frame>day 7</time_frame>
    <description>The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire</measure>
    <time_frame>day 7</time_frame>
    <description>Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.&#xD;
The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Preference for Either Device</measure>
    <time_frame>day 7</time_frame>
    <description>Participants answered a single question to determine their device preference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participnats With Difficulties Experienced When Handling the Devices</measure>
    <time_frame>1 week</time_frame>
    <description>Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Indacaterol (QAB149) Breezhaler®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tiotropium Respimat®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <description>Tiotropium via Respimat® device once a day</description>
    <arm_group_label>Tiotropium Respimat®</arm_group_label>
    <other_name>Spiriva®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indacaterol</intervention_name>
    <description>Indacaterol via Breezhaler® device once a day</description>
    <arm_group_label>Indacaterol (QAB149) Breezhaler®</arm_group_label>
    <other_name>Onbrez™</other_name>
    <other_name>Onbrize™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Male and female adults aged ≥40 years, who have signed an Informed Consent form prior&#xD;
             to initiation of any study-related procedure.&#xD;
&#xD;
          2. Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD&#xD;
             Guidelines 2010 or grade A in GOLD 2011and including:&#xD;
&#xD;
               -  Smoking history of at least 10 pack years&#xD;
&#xD;
               -  FEV1/FVC &lt; 70%&#xD;
&#xD;
        Key Exclusion criteria:&#xD;
&#xD;
          1. Previous diagnosis of asthma&#xD;
&#xD;
          2. Pregnant or nursing women&#xD;
&#xD;
          3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months&#xD;
             prior to visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Goiania</city>
        <state>GO</state>
        <zip>74110-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30150-281</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20551-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90020-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Florianopolis</city>
        <state>SC</state>
        <zip>88040-970</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>SP</state>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04039-004</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01224-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>November 9, 2016</results_first_submitted>
  <results_first_submitted_qc>November 9, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 6, 2017</results_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breezhaler</keyword>
  <keyword>Respimat</keyword>
  <keyword>Indacaterol</keyword>
  <keyword>Tiotropium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tiotropium Bromide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Total number of participants randomized to the study was 140. However, one participant did not meet an exclusion criterion. Therefore, the starting numbers in the participant flow reflect the 139 eligible randomized participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Indacaterol Breezhaler® First, Then Tiotropium Respimat®</title>
          <description>In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.</description>
        </group>
        <group group_id="P2">
          <title>Tiotropium Respimat® First, Then Indacaterol Breezhaler®</title>
          <description>In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis population contained all 140 participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>All Randomized Participants</title>
          <description>All participants who were randomized either to sequence 1 or sequence 2</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="140"/>
          </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="63.5" spread="8.2"/>
                  </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="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Correctly Used the Device at the Start of Handling the Device</title>
        <description>The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.</description>
        <time_frame>day 1</time_frame>
        <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol (QAB149) Breezhaler®</title>
            <description>Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Tiotropium Respimat®</title>
            <description>Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Correctly Used the Device at the Start of Handling the Device</title>
          <description>The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.</description>
          <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.451</p_value>
            <method>Generalized Estimating Equation (GEE)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Correctly Using the Device After One Week of Handling</title>
        <description>The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.</description>
        <time_frame>day 7</time_frame>
        <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol (QAB149) Breezhaler®</title>
            <description>Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Tiotropium Respimat®</title>
            <description>Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Correctly Using the Device After One Week of Handling</title>
          <description>The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.</description>
          <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire</title>
        <description>Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.&#xD;
The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction</description>
        <time_frame>day 7</time_frame>
        <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol (QAB149) Breezhaler®</title>
            <description>Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Tiotropium Respimat®</title>
            <description>Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire</title>
          <description>Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.&#xD;
The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction</description>
          <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.0" spread="5.7"/>
                    <measurement group_id="O2" value="44.4" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Preference for Either Device</title>
        <description>Participants answered a single question to determine their device preference.</description>
        <time_frame>day 7</time_frame>
        <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol (QAB149) Breezhaler®</title>
            <description>Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Preference for Either Device</title>
          <description>Participants answered a single question to determine their device preference.</description>
          <population>The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Breezhaler®</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respimat®</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indifferent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participnats With Difficulties Experienced When Handling the Devices</title>
        <description>Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.</description>
        <time_frame>1 week</time_frame>
        <population>The safety analysis set, which included participants who received at least one dose of study medication, was considered for the analysis. However, only participants who had observed values, were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol (QAB149) Breezhaler®</title>
            <description>Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Tiotropium Respimat®</title>
            <description>Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participnats With Difficulties Experienced When Handling the Devices</title>
          <description>Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.</description>
          <population>The safety analysis set, which included participants who received at least one dose of study medication, was considered for the analysis. However, only participants who had observed values, were analyzed.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sometime vibration of drug was not heard</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Placing capsule and inhaling drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Capsule sticks to contact when hand is wet/moist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Requiring aspiration of drug more than once</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty turning the device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty emptying the capsule in 1 aspiration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty using the device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to place the capsule in the device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient reported to be unable to place the capsule</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More difficulty handling this device than previous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unpractical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Felt that capsule was out of place</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>A total of 138 participants received at least one treatment (Respimat or Breezhaler). Two patients received only Respimat and didn't receive Breezhaler. (safety population of breezhaler was 136) and 4 patients received only Breezhaler and didn't receive Respimat (safety population of Respimat was 134).</desc>
      <group_list>
        <group group_id="E1">
          <title>Indacaterol (QAB149) Breezhaler®</title>
          <description>Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.</description>
        </group>
        <group group_id="E2">
          <title>Tiotropium Respimat®</title>
          <description>Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.0</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="7" subjects_at_risk="136"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain uppper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Saliva altered</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA">Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="136"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Nasal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="136"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01727024
org study id: CQAB149BBR02
nct id: NCT01727024
lead sponsor: 
This study compared the correct use of and patient preference for two drug delivery systems
      (inhalers) in patients with COPD
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Correctly Used the Device at the Start of Handling the Device
time frame: day 1
description: The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.
measure: Number of Participants Correctly Using the Device After One Week of Handling
time frame: day 7
description: The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.
measure: Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire
time frame: day 7
description: Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.
The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction
measure: Number of Participants With Preference for Either Device
time frame: day 7
description: Participants answered a single question to determine their device preference.
measure: Number of Participnats With Difficulties Experienced When Handling the Devices
time frame: 1 week
description: Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.
arm group label: Indacaterol (QAB149) Breezhaler®
arm group type: Experimental
description: In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
arm group label: Tiotropium Respimat®
arm group type: Active Comparator
description: In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
intervention type: Drug
intervention name: Tiotropium
description: Tiotropium via Respimat® device once a day
arm group label: Tiotropium Respimat®
other name: Spiriva®
intervention type: Drug
intervention name: Indacaterol
description: Indacaterol via Breezhaler® device once a day
arm group label: Indacaterol (QAB149) Breezhaler®
other name: Onbrez™
other name: Onbrize™
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Tiotropium Bromide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 