<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/NCT02184624</url>
  </required_header>
  <id_info>
    <org_study_id>200301</org_study_id>
    <nct_id>NCT02184624</nct_id>
  </id_info>
  <brief_title>Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices</brief_title>
  <official_title>An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices (ELLIPTA, TURBUHALER, HANDIHALER, BREEZHALER, MDI, and DISKUS/ACCUHALER) in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised, open-label, placebo, crossover, multicentre study with a single visit.&#xD;
      The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo)&#xD;
      via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they&#xD;
      are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other&#xD;
      inhaler devices that will be used in this study will be included. Furthermore, subjects who&#xD;
      are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler&#xD;
      devices that requires a capsule. The study will be conducted in the UK and the Netherlands,&#xD;
      and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will&#xD;
      be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be&#xD;
      allocated to one of the sub-studies depending on their experience of using the other inhaler&#xD;
      (i.e., depending on which other inhaler they are naïve to).&#xD;
&#xD;
      This study is designed to assess the proportion of COPD subjects making critical and overall&#xD;
      (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other&#xD;
      commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI&#xD;
      and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference&#xD;
      between the ELLIPTA inhaler and the other commercially available inhaler devices.&#xD;
&#xD;
      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.&#xD;
      TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of&#xD;
      Boehringer Ingelheim Pharma GmbH &amp; Co. KG. BREEZHALER is a registered trademark of Novartis&#xD;
      AG.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2014</start_date>
  <completion_date type="Actual">July 31, 2015</completion_date>
  <primary_completion_date type="Actual">July 31, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet</measure>
    <time_frame>Day 1</time_frame>
    <description>A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet</measure>
    <time_frame>Day 1</time_frame>
    <description>An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP</measure>
    <time_frame>Day 1</time_frame>
    <description>A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP</measure>
    <time_frame>Day 1</time_frame>
    <description>An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique</measure>
    <time_frame>Day 1</time_frame>
    <description>If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire</measure>
    <time_frame>Day 1</time_frame>
    <description>After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire</measure>
    <time_frame>Day 1</time_frame>
    <description>After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">569</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Sub-Study 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to either use ELLIPTA inhaler first and then DISKUS/ACCUHALER inhaler or use DISKUS/ACCUHALER inhaler first and then ELLIPTA inhaler.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-Study 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to either use ELLIPTA inhaler first and then MDI inhaler or use MDI inhaler first and then ELLIPTA inhaler.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-Study 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to either use ELLIPTA inhaler first and then TURBUHALER inhaler or use TURBUHALER inhaler first and then ELLIPTA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-Study 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to either use ELLIPTA inhaler first and then HANDIHALER inhaler or use HANDIHALER inhaler first and then ELLIPTA inhaler.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-Study 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to either use ELLIPTA inhaler first and then BREEZEHALER inhaler or use BREEZEHALER inhaler first and then ELLIPTA inhaler.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ELLIPTA</intervention_name>
    <description>Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.</description>
    <arm_group_label>Sub-Study 1</arm_group_label>
    <arm_group_label>Sub-Study 2</arm_group_label>
    <arm_group_label>Sub-Study 3</arm_group_label>
    <arm_group_label>Sub-Study 4</arm_group_label>
    <arm_group_label>Sub-Study 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DISKUS/ACCUHALER</intervention_name>
    <description>Placebo inhaler with one blister strip containing lactose monohydrate.</description>
    <arm_group_label>Sub-Study 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MDI</intervention_name>
    <description>Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).</description>
    <arm_group_label>Sub-Study 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TURBUHALER</intervention_name>
    <description>Placebo inhaler containing lactose monohydrate.</description>
    <arm_group_label>Sub-Study 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HANDIHALER</intervention_name>
    <description>Placebo inhaler containing lactose monohydrate in a capsule.</description>
    <arm_group_label>Sub-Study 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BREEZEHALER</intervention_name>
    <description>Placebo inhaler containing lactose monohydrate in a capsule.</description>
    <arm_group_label>Sub-Study 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent: Subject must give their signed and dated written informed consent to&#xD;
             participate in the study; Subject understands and is willing, able, and likely to&#xD;
             comply with study procedures and restrictions; Subject must be able to read,&#xD;
             comprehend, and record information in Dutch and/or English.&#xD;
&#xD;
          -  Age: &gt;=40 years of age&#xD;
&#xD;
          -  Gender: Male or female subjects.&#xD;
&#xD;
          -  Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with&#xD;
             the definition by the American Thoracic Society/European Respiratory Society.&#xD;
             Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment,&#xD;
             and depression or anxiety) will be documented as relevant to inhaler use.&#xD;
&#xD;
          -  COPD treatment: All patients should be currently receiving treatment for COPD.&#xD;
&#xD;
          -  Must be naïve to using ELLIPTA inhaler and at least one other inhaler device. Subjects&#xD;
             who are naïve to the BREEZEHALER and HANDIHALER inhalers must be naïve to all other&#xD;
             inhaler devices that requires a capsule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior&#xD;
             history of asthma are eligible if they have a current diagnosis of COPD.&#xD;
&#xD;
          -  Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or&#xD;
             magnesium stearate or to any other excipient.&#xD;
&#xD;
          -  Subjects who are currently participating in another randomised pharmacological&#xD;
             interventional trial.&#xD;
&#xD;
          -  Inability to Read: In the opinion of the investigator, any subject who is unable to&#xD;
             read and/or would not be able to complete a questionnaire and understand verbal&#xD;
             instructions.&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Almere</city>
        <zip>1311 RL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beek</city>
        <zip>6191 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Enschede</city>
        <zip>7513 ER</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kloosterhaar</city>
        <zip>7694 AC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nijverdal</city>
        <zip>7442 LS</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zutphen</city>
        <zip>7207 AE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>January 31, 2017</results_first_submitted>
  <results_first_submitted_qc>January 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2017</results_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BREEZHALER</keyword>
  <keyword>DISKUS/ACCUHALER</keyword>
  <keyword>MDI</keyword>
  <keyword>Inhaler preference</keyword>
  <keyword>Overall inhaler error</keyword>
  <keyword>HANDIHALER</keyword>
  <keyword>Ease of use</keyword>
  <keyword>TURBUHALER</keyword>
  <keyword>ELLIPTA</keyword>
  <keyword>Critical inhaler error</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>200301</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>200301</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>200301</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>200301</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>200301</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>200301</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>200301</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted between 28 August 2014 and 31 July 2015 at 8 centers, 6 in the Netherlands and 2 in the United Kingdom. Only participants who were naïve to the ELLIPTA inhaler and to one of the other inhaler devices that was used in this study were included.</recruitment_details>
      <pre_assignment_details>A total of 575 participants were enrolled in the study out of them 8 failed in screening and remaining 567 were randomized and included in intent to treat population. Participants were allocated to a particular sub-study depending on their experience of using the other inhaler (i.e., depending on which other inhaler they were naïve to using).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily Chronic Obstructive Pulmonary Disease (COPD) maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="P2">
          <title>Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI)</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="P3">
          <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="P4">
          <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="P5">
          <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="171"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="118"/>
                <participants group_id="P5" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="171"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="118"/>
                <participants group_id="P5" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="B2">
          <title>Sub-study 2: ELLIPTA Vs MDI</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="B3">
          <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="B4">
          <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="B5">
          <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="171"/>
            <count group_id="B2" value="80"/>
            <count group_id="B3" value="100"/>
            <count group_id="B4" value="118"/>
            <count group_id="B5" value="98"/>
            <count group_id="B6" value="567"/>
          </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="67.8" spread="7.41"/>
                    <measurement group_id="B2" value="65.6" spread="8.76"/>
                    <measurement group_id="B3" value="68.1" spread="8.66"/>
                    <measurement group_id="B4" value="67.3" spread="8.98"/>
                    <measurement group_id="B5" value="67.2" spread="8.17"/>
                    <measurement group_id="B6" value="67.3" spread="8.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="72"/>
                    <measurement group_id="B5" value="47"/>
                    <measurement group_id="B6" value="342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African American/African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - White/Caucasian/European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="118"/>
                    <measurement group_id="B5" value="96"/>
                    <measurement group_id="B6" value="562"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet</title>
        <description>A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.</description>
        <time_frame>Day 1</time_frame>
        <population>Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet.</population>
        <group_list>
          <group group_id="O1">
            <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O2">
            <title>Sub-study 2: ELLIPTA Vs MDI</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O3">
            <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O4">
            <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O5">
            <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet</title>
          <description>A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.</description>
          <population>Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="171"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="118"/>
                <count group_id="O5" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Error with only ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with only non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="38"/>
                    <measurement group_id="O5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with both inhalers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="5"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet</title>
        <description>An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.</description>
        <time_frame>Day 1</time_frame>
        <population>Modified Intent-to-Treat Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O2">
            <title>Sub-study 2: ELLIPTA Vs MDI</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O3">
            <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O4">
            <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O5">
            <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet</title>
          <description>An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.</description>
          <population>Modified Intent-to-Treat Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="171"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="118"/>
                <count group_id="O5" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Error with only ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with only non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="45"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with both inhalers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="33"/>
                    <measurement group_id="O5" value="22"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP</title>
        <description>A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.</description>
        <time_frame>Day 1</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O2">
            <title>Sub-study 2: ELLIPTA Vs MDI</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O3">
            <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O4">
            <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O5">
            <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP</title>
          <description>A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="171"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="118"/>
                <count group_id="O5" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Error with only ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with only non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with both inhalers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>0.480</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.044</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.025</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.014</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP</title>
        <description>An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.</description>
        <time_frame>Day 1</time_frame>
        <population>Modified Intent-to-Treat Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O2">
            <title>Sub-study 2: ELLIPTA Vs MDI</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O3">
            <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O4">
            <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O5">
            <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP</title>
          <description>An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.</description>
          <population>Modified Intent-to-Treat Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="171"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="118"/>
                <count group_id="O5" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Error with only ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with only non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Error with both inhalers</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="0"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique</title>
        <description>If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.</description>
        <time_frame>Day 1</time_frame>
        <population>Modified Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O2">
            <title>Sub-study 2: ELLIPTA Vs MDI</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O3">
            <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O4">
            <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O5">
            <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique</title>
          <description>If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.</description>
          <population>Modified Intent-to-Treat Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="171"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="118"/>
                <count group_id="O5" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Zero HCP Instructions , ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="69"/>
                    <measurement group_id="O4" value="67"/>
                    <measurement group_id="O5" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zero HCP Instructions , Non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="45"/>
                    <measurement group_id="O5" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One HCP Instructions , ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="38"/>
                    <measurement group_id="O5" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One HCP Instructions , Non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="52"/>
                    <measurement group_id="O4" value="44"/>
                    <measurement group_id="O5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two HCP Instructions , ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two HCP Instructions , Non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three HCP Instructions , ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Three HCP Instructions , Non-ELLIPTA inhaler</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for DISKUS/ACCUHALER inhaler</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for MDI inhaler</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for TURBUHALER inhaler</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for HANDIHALER inhaler</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for BREEZHALER inhaler</p_value_desc>
            <method>Wilcoxon signed rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire</title>
        <description>After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.</description>
        <time_frame>Day 1</time_frame>
        <population>Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O2">
            <title>Sub-study 2: ELLIPTA Vs MDI</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O3">
            <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O4">
            <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O5">
            <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire</title>
          <description>After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.</description>
          <population>Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="118"/>
                <count group_id="O5" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ELLIPTA preferred</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="75"/>
                    <measurement group_id="O3" value="86"/>
                    <measurement group_id="O4" value="87"/>
                    <measurement group_id="O5" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-ELLIPTA Device Preferred</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="8"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device as assessed by the 'preference' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring MDI device as assessed by the 'preference' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device as assessed by the 'preference' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device as assessed by the 'preference' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device as assessed by the 'preference' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire</title>
        <description>After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported</description>
        <time_frame>Day 1</time_frame>
        <population>Modified Intent-to-Treat Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O2">
            <title>Sub-study 2: ELLIPTA Vs MDI</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O3">
            <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O4">
            <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
          <group group_id="O5">
            <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
            <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire</title>
          <description>After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported</description>
          <population>Modified Intent-to-Treat Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="171"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="118"/>
                <count group_id="O5" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RATED HIGHER FOR ELLIPTA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="72"/>
                    <measurement group_id="O4" value="78"/>
                    <measurement group_id="O5" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RATED HIGHER FOR NON-ELLIPTA DEVICES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RATED SAME FOR BOTH TYPES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="22"/>
                  </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>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device by the 'ease of use' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring MDI device by the 'ease of use' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device by the 'ease of use' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device by the 'ease of use' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device by the 'ease of use' questionnaire</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events and serious adverse events were collected from the start of study treatment (Day 1) and until the follow up contact.</time_frame>
      <desc>Intent-to-Treat Population comprised of all participants who had been randomized and used at least one study inhaler after reading patient information leaflet.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="E2">
          <title>Sub-study 2: ELLIPTA Vs MDI</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="E3">
          <title>Sub-study 3: ELLIPTA Vs TURBUHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="E4">
          <title>Sub-study 4: ELLIPTA Vs HANDIHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</description>
        </group>
        <group group_id="E5">
          <title>Sub-study 5: ELLIPTA Vs BREEZHALER</title>
          <description>Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.</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="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="171"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="98"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</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/NCT02184624
org study id: 200301
nct id: NCT02184624
lead sponsor: 
has dmc: No
This is a randomised, open-label, placebo, crossover, multicentre study with a single visit.
      The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo)
      via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they
      are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other
      inhaler devices that will be used in this study will be included. Furthermore, subjects who
      are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler
      devices that requires a capsule. The study will be conducted in the UK and the Netherlands,
      and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will
      be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be
      allocated to one of the sub-studies depending on their experience of using the other inhaler
      (i.e., depending on which other inhaler they are naïve to).

      This study is designed to assess the proportion of COPD subjects making critical and overall
      (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other
      commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI
      and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference
      between the ELLIPTA inhaler and the other commercially available inhaler devices.

      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.
      TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of
      Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis
      AG.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet
time frame: Day 1
description: A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.
measure: Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet
time frame: Day 1
description: An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.
measure: Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP
time frame: Day 1
description: A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.
measure: Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP
time frame: Day 1
description: An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.
measure: Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique
time frame: Day 1
description: If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.
measure: Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire
time frame: Day 1
description: After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.
measure: Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire
time frame: Day 1
description: After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported
arm group label: Sub-Study 1
arm group type: Experimental
description: Subjects will be randomized to either use ELLIPTA inhaler first and then DISKUS/ACCUHALER inhaler or use DISKUS/ACCUHALER inhaler first and then ELLIPTA inhaler.
arm group label: Sub-Study 2
arm group type: Experimental
description: Subjects will be randomized to either use ELLIPTA inhaler first and then MDI inhaler or use MDI inhaler first and then ELLIPTA inhaler.
arm group label: Sub-Study 3
arm group type: Experimental
description: Subjects will be randomized to either use ELLIPTA inhaler first and then TURBUHALER inhaler or use TURBUHALER inhaler first and then ELLIPTA.
arm group label: Sub-Study 4
arm group type: Experimental
description: Subjects will be randomized to either use ELLIPTA inhaler first and then HANDIHALER inhaler or use HANDIHALER inhaler first and then ELLIPTA inhaler.
arm group label: Sub-Study 5
arm group type: Experimental
description: Subjects will be randomized to either use ELLIPTA inhaler first and then BREEZEHALER inhaler or use BREEZEHALER inhaler first and then ELLIPTA inhaler.
intervention type: Device
intervention name: ELLIPTA
description: Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.
arm group label: Sub-Study 1
arm group label: Sub-Study 2
arm group label: Sub-Study 3
arm group label: Sub-Study 4
arm group label: Sub-Study 5
intervention type: Device
intervention name: DISKUS/ACCUHALER
description: Placebo inhaler with one blister strip containing lactose monohydrate.
arm group label: Sub-Study 1
intervention type: Device
intervention name: MDI
description: Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).
arm group label: Sub-Study 2
intervention type: Device
intervention name: TURBUHALER
description: Placebo inhaler containing lactose monohydrate.
arm group label: Sub-Study 3
intervention type: Device
intervention name: HANDIHALER
description: Placebo inhaler containing lactose monohydrate in a capsule.
arm group label: Sub-Study 4
intervention type: Device
intervention name: BREEZEHALER
description: Placebo inhaler containing lactose monohydrate in a capsule.
arm group label: Sub-Study 5
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
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facility: 
country: Netherlands
country: United Kingdom
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
study doc: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 