<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/NCT02195284</url>
  </required_header>
  <id_info>
    <org_study_id>200330</org_study_id>
    <nct_id>NCT02195284</nct_id>
  </id_info>
  <brief_title>To Study Device Attributes by Investigating Errors Made in Use, Ease of Use and Preference Among Different Inhalers in Subjects With Asthma</brief_title>
  <official_title>An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, and Ease of Use and Preference Between a Number of Inhaler Devices (ELLIPTA, DISKUS/ACCUHALER, TURBUHALER, and MDI) in Adult Subjects With Asthma (Study 200330)</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 study is designed to assess the proportion of asthma subjects making critical and&#xD;
      non-critical errors made in using ELLIPTA® inhaler compared with other commercially available&#xD;
      inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and DISKUS/ACCUHALER®.&#xD;
      This study will also assess the ease of use and preference between the ELLIPTA inhaler and&#xD;
      the other commercially available inhaler devices. This is a randomized, open-label, placebo,&#xD;
      crossover, multicentre study with a single visit. The study will comprise three sub-studies.&#xD;
      Subjects will receive inactive treatment (placebo) via the ELLIPTA inhaler and one of the&#xD;
      other inhaler devices depending on the sub-study they are allocated to. Only subjects who are&#xD;
      naïve to the ELLIPTA inhaler and to one of the other inhalers that will be used in this study&#xD;
      will be included. The study will be conducted in the Netherlands and the UK, and comprises&#xD;
      one visit only. A sufficient number of subjects (at least 190) with asthma will be screened&#xD;
      and 180 will be randomized to one of the three sub-studies. Eligible subjects will be&#xD;
      allocated to one of the sub-studies in the following order depending on their experience of&#xD;
      using the other inhaler (i.e., depending on which other inhaler they are naïve to).&#xD;
&#xD;
      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.&#xD;
      TURBUHALER is a registered trademark of AstraZeneca.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-interventional study and not an observational study and therefore some fields&#xD;
      are not applicable for the CT.gov observational study design. It would be preferential to&#xD;
      have the field populated as &quot;not applicable&quot; for sampling method, time perspective, and&#xD;
      observational study model as they don't apply to this study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects making at least one critical error after reading the patient information leaflet</measure>
    <time_frame>Day 1</time_frame>
    <description>In each sub-study, subjects will be asked to read the patient instruction leaflet of the first device and then asked to demonstrate inhaler use. Any errors (critical or non-critical) made by the subject while using the first inhaler will be recorded by the health care professional (HCP). The same procedures will be followed for the second inhaler. A critical error is defined as an error that is most likely to result in no or only minimal medication being inhaled</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects making at least one critical error after the first instruction from HCP</measure>
    <time_frame>Day 1</time_frame>
    <description>In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct use of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors will be recorded by the HCP. The same procedures will be followed for the second inhaler. A critical error is defined as an error that is most likely to result in no or only minimal medication being inhaled</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects making at least one overall error after reading the patient information leaflet</measure>
    <time_frame>Day 1</time_frame>
    <description>In each sub-study, subjects will be asked to read the patient instruction leaflet of the first device and then asked to demonstrate inhaler use. Any errors (critical or non-critical) made by the subject while using the first inhaler will be recorded by the HCP. The same procedures will be followed for the second inhaler. An overall error includes a critical and non-critical error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of subjects making at least one overall error after the first instruction on use by the HCP</measure>
    <time_frame>Day 1</time_frame>
    <description>In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct use of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors (critical or non-critical) will be recorded by the HCP. The same procedures will be followed for the second inhaler. An overall error includes a critical and non-critical error</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of instructions (maximum three times) from the HCP which are needed to demonstrate adequate inhalation technique</measure>
    <time_frame>Day 1</time_frame>
    <description>In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct usage of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors will be recorded by the HCP. The same procedures will be repeated if the subject continues to make errors in the use of the inhaler. In total, the HCP will demonstrate the use of the inhaler up to three times. Same procedures will be followed for second inhaler.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of subjects who prefer the ELLIPTA device compared to the other devices as assessed by the 'preference' questionnaire</measure>
    <time_frame>Day 1</time_frame>
    <description>After completing the demonstration procedures of the inhalers, the HCP will ask the subject a number of questions from preference questionnaire after completing the ease of use questionnaire. Preference questionnaire will consist of eight questions with each question having one response to chose from 3 options of preference (Other inhaler device, ELLIPTA inhaler device, No preference)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of subjects who found the ELLIPTA device 'easy to use' compared with the other devices' 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 will ask the subject a number of questions from ease of use questionnaire. Ease of use questionnaire will consist of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question will have one response to chose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Asthma</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 (metered-dose inhaler) or use MDI first and then ELLIPTA inahler</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 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>
  </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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent: Subject must give their signed and dated written informed consent to&#xD;
             participate; Subject understands and is willing, able, and likely to comply with study&#xD;
             procedures and restrictions; Subject must be able to read, comprehend, and record&#xD;
             information in Dutch and/or English&#xD;
&#xD;
          -  Age: &gt;=18 years of age&#xD;
&#xD;
          -  Gender: Male or female subjects.&#xD;
&#xD;
          -  Asthma Diagnosis: A diagnosis of asthma as defined by the National Institutes of&#xD;
             Health. Comorbidities (rheumatoid arthritis or other locomotor problems, visual&#xD;
             impairment, and depression or anxiety) will be documented as relevant to inhaler use.&#xD;
&#xD;
          -  Asthma treatment: All subjects should be currently receiving treatment for asthma.&#xD;
&#xD;
          -  Must be naive to using ELLIPTA inhaler and at least one other inhaler device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of&#xD;
             COPD only.&#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>18 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>Enschede</city>
        <zip>7513 ER</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>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>November 19, 2015</last_update_submitted>
  <last_update_submitted_qc>November 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inhaler preference</keyword>
  <keyword>Overall inhaler error</keyword>
  <keyword>DISKUS/ACCUHALER</keyword>
  <keyword>MDI</keyword>
  <keyword>TURBUHALER</keyword>
  <keyword>ELLIPTA</keyword>
  <keyword>Ease of use</keyword>
  <keyword>Critical inhaler error</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 30, 2017</submitted>
    <returned>March 17, 2017</returned>
    <submitted>May 5, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>August 14, 2017</submitted>
    <returned>February 16, 2018</returned>
    <submitted>February 22, 2018</submitted>
    <submission_canceled>August 15, 2018</submission_canceled>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02195284
org study id: 200330
nct id: NCT02195284
lead sponsor: 
has dmc: No
This study is designed to assess the proportion of asthma subjects making critical and
      non-critical errors made in using ELLIPTA® inhaler compared with other commercially available
      inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and DISKUS/ACCUHALER®.
      This study will also assess the ease of use and preference between the ELLIPTA inhaler and
      the other commercially available inhaler devices. This is a randomized, open-label, placebo,
      crossover, multicentre study with a single visit. The study will comprise three 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 allocated to. Only subjects who are
      naïve to the ELLIPTA inhaler and to one of the other inhalers that will be used in this study
      will be included. The study will be conducted in the Netherlands and the UK, and comprises
      one visit only. A sufficient number of subjects (at least 190) with asthma will be screened
      and 180 will be randomized to one of the three sub-studies. Eligible subjects will be
      allocated to one of the sub-studies in the following order depending on their experience of
      using the other inhaler (i.e., depending on which other inhaler they are naïve to).

      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.
      TURBUHALER is a registered trademark of AstraZeneca.
This is a non-interventional study and not an observational study and therefore some fields
      are not applicable for the CT.gov observational study design. It would be preferential to
      have the field populated as "not applicable" for sampling method, time perspective, and
      observational study model as they don't apply to this study design.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Percentage of subjects making at least one critical error after reading the patient information leaflet
time frame: Day 1
description: In each sub-study, subjects will be asked to read the patient instruction leaflet of the first device and then asked to demonstrate inhaler use. Any errors (critical or non-critical) made by the subject while using the first inhaler will be recorded by the health care professional (HCP). The same procedures will be followed for the second inhaler. A critical error is defined as an error that is most likely to result in no or only minimal medication being inhaled
measure: Percentage of subjects making at least one critical error after the first instruction from HCP
time frame: Day 1
description: In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct use of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors will be recorded by the HCP. The same procedures will be followed for the second inhaler. A critical error is defined as an error that is most likely to result in no or only minimal medication being inhaled
measure: Percentage of subjects making at least one overall error after reading the patient information leaflet
time frame: Day 1
description: In each sub-study, subjects will be asked to read the patient instruction leaflet of the first device and then asked to demonstrate inhaler use. Any errors (critical or non-critical) made by the subject while using the first inhaler will be recorded by the HCP. The same procedures will be followed for the second inhaler. An overall error includes a critical and non-critical error
measure: The percentage of subjects making at least one overall error after the first instruction on use by the HCP
time frame: Day 1
description: In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct use of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors (critical or non-critical) will be recorded by the HCP. The same procedures will be followed for the second inhaler. An overall error includes a critical and non-critical error
measure: The number of instructions (maximum three times) from the HCP which are needed to demonstrate adequate inhalation technique
time frame: Day 1
description: In each sub-study, if the subject makes any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP will demonstrate the correct usage of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors will be recorded by the HCP. The same procedures will be repeated if the subject continues to make errors in the use of the inhaler. In total, the HCP will demonstrate the use of the inhaler up to three times. Same procedures will be followed for second inhaler.
measure: The percentage of subjects who prefer the ELLIPTA device compared to the other devices as assessed by the 'preference' questionnaire
time frame: Day 1
description: After completing the demonstration procedures of the inhalers, the HCP will ask the subject a number of questions from preference questionnaire after completing the ease of use questionnaire. Preference questionnaire will consist of eight questions with each question having one response to chose from 3 options of preference (Other inhaler device, ELLIPTA inhaler device, No preference)
measure: The percentage of subjects who found the ELLIPTA device 'easy to use' compared with the other devices' as assessed by the 'ease of use' questionnaire
time frame: Day 1
description: After completing the demonstration procedures of the inhalers, the HCP will ask the subject a number of questions from ease of use questionnaire. Ease of use questionnaire will consist of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question will have one response to chose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult)
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 (metered-dose inhaler) or use MDI first and then ELLIPTA inahler
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 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
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
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma
submitted: January 30, 2017
returned: March 17, 2017
submitted: May 5, 2017
submission canceled: Unknown
submitted: August 14, 2017
returned: February 16, 2018
submitted: February 22, 2018
submission canceled: August 15, 2018