Back to resultsA Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
ELLIPTA
BREEZHALER
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring ELLIPTA, BREEZHALER, Dry powder inhaler, Asthma
Eligibility Criteria
Inclusion Criteria:
- Participants must be aged 18 years or older at the time of signing the informed consent.
- Participants who have a confirmed mild or moderate asthma diagnosis as per Global Initiative for Asthma (GINA), 2020.
- Participants must be on asthma maintenance therapy (Inhaled corticosteroids [ICS] or ICS/ Long acting beta 2-agonist [LABA]) for at least 12 weeks prior to study participation.
- Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers.
- Females who are not pregnant or not planning a pregnancy during the study or not Lactating.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
- Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders.
- History of hypersensitivity to any components of the study inhaler (e.g., lactose). In addition, participants with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
- Historical or current evidence of clinically significant or rapidly progressing or unstable disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.
- Drug/alcohol abuse: Participants with a known or suspected alcohol or drug abuse, which in the opinion of the investigator could interfere with the participant's proper completion of the protocol requirement.
- A participant will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator, as well as employees of GSK or Novartis.
- Inability to Read: In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions.
- Medical and physical conditions that in the opinion of the investigator could impact the ability of the participant to manipulate the inhaler.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
ELLIPTA/ BREEZHALER/Questionnaire version 1
ELLIPTA/ BREEZHALER/Questionnaire version 2
BREEZHALER/ ELLIPTA/Questionnaire version 1
BREEZHALER/ ELLIPTA/Questionnaire version 2
Arm Description
Participants received placebo ELLIPTA Dry Powder Inhaler (DPI) followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and visual analogue scale (VAS) on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
Participants received placebo ELLIPTA DPI followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
Outcomes
Primary Outcome Measures
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. Percentage values are rounded off.
Secondary Outcome Measures
Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
Participants were asked to demonstrate inhaler use after reading PIL. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 instructions on the use of the inhaler. Same procedure was followed for second inhaler. Percentage of participants making at least one critical error after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported. Percentage values are rounded off.
Percentage of Participants Making at Least One Overall Error After Reading PIL
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. An overall error was any error in inhaler technique which includes a critical and non-critical error. Percentage values are rounded off.
Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
Participants were asked to demonstrate inhaler use after reading PIL. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 instructions on the use of the inhaler. Same procedure was followed for second inhaler. An overall error was any error in inhaler technique which includes a critical and non-critical error. Percentage of participants making at least one overall error after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported. Percentage values are rounded off.
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Participants were asked to demonstrate inhaler use after reading PIL. If participant made any error according to error checklists, the HCP provided instructions on correct use of inhaler to participant and participant was then asked to demonstrate inhaler use again. Critical error was any error which most likely to result in no or significantly reduced medication being inhaled. An overall error was any error in inhaler technique, which includes a critical and non-critical. Any error made by the participant was recorded by the HCP in checklist. The same procedure was repeated if the participant continued to make errors in the use of inhaler. In total, HCP provided up to 3 time instructions on correct use of inhaler. Same procedure was followed for second inhaler. The number of critical and overall errors made by participants after reading PIL and after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported.
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
Participants were asked to demonstrate inhaler use after reading PIL. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 times instructions on the correct use of inhaler. Same procedure was followed for second inhaler. Percentage of participants who required zero, 1st, 2nd and 3rd instruction from HCP to demonstrate correct inhaler use were reported. Percentage values are rounded off.
Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1)
Participants were asked to demonstrate inhaler use after reading PIL and any error made by the participant was recorded by the HCP in the checklist. Time taken to demonstrate inhaler use after reading PIL without HCP intervention was the amount of time taken to correctly demonstrate inhaler use without HCP intervention. T1 was calculated from the start of inhaler demonstration by the participant after reading the PIL until completion of the first attempt.
Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2)
Time taken by HCP to demonstrate the correct use of inhaler was the time from when the HCP started to instruct the participant until correct use was demonstrated. It includes the time used by the HCP for re-instructing the participants throughout. T2 was calculated from the first instruction provided by the HCP until demonstration of correct use. Up to 3 further attempts were made after completion of the first attempt.
Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2)
Participants were asked to demonstrate inhaler use after reading PIL and any error made by the participant was recorded by the HCP in the checklist. Total time taken for demonstration of correct use after reading PIL was the time from when the participant started the demonstration until correct use is demonstrated (4 attempts= once after the reading the PIL and following instruction from investigator up to 3 times). T1+T2 was calculated from the start of inhaler demonstration after reading the PIL until correct demonstration was observed.
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Participant were asked to complete the ease of use questionnaire for the DPI once error assessment of each inhaler was completed. This was a series of 6 questions (Ease of use rating, Telling how many doses were left in inhaler, Learning how to use inhaler, Handling the inhaler, Preparing inhaler and Holding inhaler while using it). Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Participants were asked to rate based on their ease of use experience with device using a scale ranging from 1 (very easy) to 5 (very difficult). A higher rating indicated that the inhaler was difficult to use and a lower rating indicated that inhaler was easier to use. This questionnaire was completed for the first device before moving to the critical errors assessment of the second device. Data has been categorized and reported as 'Very easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult' with respect to each question.
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
The ease-of-use questionnaire consists of a series of 6 questions (Ease of use rating, Telling how many doses were left in inhaler, Learning how to use inhaler, Handling inhaler, Preparing inhaler and Holding inhaler while using it). Each question had one response to choose from 5 options of ease of use(Very easy, easy, neutral, difficult and very difficult). Participants were asked to rate based on their ease of use experience with device using a scale ranging from 1(very easy) to 5(very difficult). A higher rating indicated that inhaler was difficult to use and a lower rating indicated that inhaler was easy to use. This questionnaire was completed for first device before moving to critical errors assessment of second device. Participant who responded Very Easy or Easy was considered Easy and participant who responded Neutral, Difficult or Very Difficult was considered Difficult. Data has been categorized and reported as Easy and Difficult with respect to each question
Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler
Participants were asked the question regarding their willingness to continue with the inhaler using a visual analogue scale ranging from 0 (not willing) to 100 (definitely willing) after completion of the critical errors assessment for each inhaler and the ease of use questionnaire for that inhaler. Participants marked on the VAS scale, how willing they were to continue using the inhaler. That mark was measured with a ruler to determine the numerical score. It ranges from 0 to 100 where, higher score on the scale indicates better outcome, means participant was definitely willing to continue using the inhaler.
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Participants were asked to complete the assigned preference questionnaires after completing the errors in use assessment for both devices. Participants were asked to provide their responses in terms of their preference to the ELLIPTA inhaler or BREEZHALER inhaler or No preference. Participants preference was assessed using series of 7 questions (Preferred inhaler-overall, Preference based on the number of steps to take the medication, Preference based on the time needed to take the medication, Preference based on how easy the inhaler was to use, Preference based on the size of the inhaler, Preference based on the comfort of the mouthpiece and Preference based on the ease of opening the inhaler). Participants had to choose one response from 3 preference options (ELLIPTA inhaler or BREEZHALER inhaler or No preference).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04813354
Brief Title
A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma
Official Title
A Randomized, Multi-center, Open-label, Cross-over Study Comparing Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Dry Powder Inhaler Versus the BREEZHALER Dry Powder Inhaler, in Adult Participants With Mild to Moderate Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to provide data in adult participants with mild to moderate asthma to assist healthcare professionals (HCPs) in assessing various attributes of ELLIPTA and BREEZHALER DPIs, by comparing the incidence of critical and overall errors, participant preference, willingness to continue with the inhaler and time to correct use. ELLIPTA® is a registered trademark of GlaxoSmithKline (GSK) and BREEZHALER® is a registered trademark of Novartis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
ELLIPTA, BREEZHALER, Dry powder inhaler, Asthma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
The study will be a randomized, multi-center, open label, placebo- controlled device handling study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELLIPTA/ BREEZHALER/Questionnaire version 1
Arm Type
Experimental
Arm Description
Participants received placebo ELLIPTA Dry Powder Inhaler (DPI) followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and visual analogue scale (VAS) on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
Arm Title
ELLIPTA/ BREEZHALER/Questionnaire version 2
Arm Type
Experimental
Arm Description
Participants received placebo ELLIPTA DPI followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
Arm Title
BREEZHALER/ ELLIPTA/Questionnaire version 1
Arm Type
Experimental
Arm Description
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
Arm Title
BREEZHALER/ ELLIPTA/Questionnaire version 2
Arm Type
Experimental
Arm Description
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
Intervention Type
Device
Intervention Name(s)
ELLIPTA
Intervention Description
ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1
ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2
Intervention Type
Device
Intervention Name(s)
BREEZHALER
Intervention Description
ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1
ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2
Primary Outcome Measure Information:
Title
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
Description
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. Percentage values are rounded off.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
Description
Participants were asked to demonstrate inhaler use after reading PIL. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 instructions on the use of the inhaler. Same procedure was followed for second inhaler. Percentage of participants making at least one critical error after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported. Percentage values are rounded off.
Time Frame
Day 1
Title
Percentage of Participants Making at Least One Overall Error After Reading PIL
Description
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. An overall error was any error in inhaler technique which includes a critical and non-critical error. Percentage values are rounded off.
Time Frame
Day 1
Title
Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
Description
Participants were asked to demonstrate inhaler use after reading PIL. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 instructions on the use of the inhaler. Same procedure was followed for second inhaler. An overall error was any error in inhaler technique which includes a critical and non-critical error. Percentage of participants making at least one overall error after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported. Percentage values are rounded off.
Time Frame
Day 1
Title
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Description
Participants were asked to demonstrate inhaler use after reading PIL. If participant made any error according to error checklists, the HCP provided instructions on correct use of inhaler to participant and participant was then asked to demonstrate inhaler use again. Critical error was any error which most likely to result in no or significantly reduced medication being inhaled. An overall error was any error in inhaler technique, which includes a critical and non-critical. Any error made by the participant was recorded by the HCP in checklist. The same procedure was repeated if the participant continued to make errors in the use of inhaler. In total, HCP provided up to 3 time instructions on correct use of inhaler. Same procedure was followed for second inhaler. The number of critical and overall errors made by participants after reading PIL and after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported.
Time Frame
Day 1
Title
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
Description
Participants were asked to demonstrate inhaler use after reading PIL. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 times instructions on the correct use of inhaler. Same procedure was followed for second inhaler. Percentage of participants who required zero, 1st, 2nd and 3rd instruction from HCP to demonstrate correct inhaler use were reported. Percentage values are rounded off.
Time Frame
Day 1
Title
Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1)
Description
Participants were asked to demonstrate inhaler use after reading PIL and any error made by the participant was recorded by the HCP in the checklist. Time taken to demonstrate inhaler use after reading PIL without HCP intervention was the amount of time taken to correctly demonstrate inhaler use without HCP intervention. T1 was calculated from the start of inhaler demonstration by the participant after reading the PIL until completion of the first attempt.
Time Frame
Day 1
Title
Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2)
Description
Time taken by HCP to demonstrate the correct use of inhaler was the time from when the HCP started to instruct the participant until correct use was demonstrated. It includes the time used by the HCP for re-instructing the participants throughout. T2 was calculated from the first instruction provided by the HCP until demonstration of correct use. Up to 3 further attempts were made after completion of the first attempt.
Time Frame
Day 1
Title
Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2)
Description
Participants were asked to demonstrate inhaler use after reading PIL and any error made by the participant was recorded by the HCP in the checklist. Total time taken for demonstration of correct use after reading PIL was the time from when the participant started the demonstration until correct use is demonstrated (4 attempts= once after the reading the PIL and following instruction from investigator up to 3 times). T1+T2 was calculated from the start of inhaler demonstration after reading the PIL until correct demonstration was observed.
Time Frame
Day 1
Title
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Description
Participant were asked to complete the ease of use questionnaire for the DPI once error assessment of each inhaler was completed. This was a series of 6 questions (Ease of use rating, Telling how many doses were left in inhaler, Learning how to use inhaler, Handling the inhaler, Preparing inhaler and Holding inhaler while using it). Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Participants were asked to rate based on their ease of use experience with device using a scale ranging from 1 (very easy) to 5 (very difficult). A higher rating indicated that the inhaler was difficult to use and a lower rating indicated that inhaler was easier to use. This questionnaire was completed for the first device before moving to the critical errors assessment of the second device. Data has been categorized and reported as 'Very easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult' with respect to each question.
Time Frame
Day 1
Title
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Description
The ease-of-use questionnaire consists of a series of 6 questions (Ease of use rating, Telling how many doses were left in inhaler, Learning how to use inhaler, Handling inhaler, Preparing inhaler and Holding inhaler while using it). Each question had one response to choose from 5 options of ease of use(Very easy, easy, neutral, difficult and very difficult). Participants were asked to rate based on their ease of use experience with device using a scale ranging from 1(very easy) to 5(very difficult). A higher rating indicated that inhaler was difficult to use and a lower rating indicated that inhaler was easy to use. This questionnaire was completed for first device before moving to critical errors assessment of second device. Participant who responded Very Easy or Easy was considered Easy and participant who responded Neutral, Difficult or Very Difficult was considered Difficult. Data has been categorized and reported as Easy and Difficult with respect to each question
Time Frame
Day 1
Title
Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler
Description
Participants were asked the question regarding their willingness to continue with the inhaler using a visual analogue scale ranging from 0 (not willing) to 100 (definitely willing) after completion of the critical errors assessment for each inhaler and the ease of use questionnaire for that inhaler. Participants marked on the VAS scale, how willing they were to continue using the inhaler. That mark was measured with a ruler to determine the numerical score. It ranges from 0 to 100 where, higher score on the scale indicates better outcome, means participant was definitely willing to continue using the inhaler.
Time Frame
Day 1
Title
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Description
Participants were asked to complete the assigned preference questionnaires after completing the errors in use assessment for both devices. Participants were asked to provide their responses in terms of their preference to the ELLIPTA inhaler or BREEZHALER inhaler or No preference. Participants preference was assessed using series of 7 questions (Preferred inhaler-overall, Preference based on the number of steps to take the medication, Preference based on the time needed to take the medication, Preference based on how easy the inhaler was to use, Preference based on the size of the inhaler, Preference based on the comfort of the mouthpiece and Preference based on the ease of opening the inhaler). Participants had to choose one response from 3 preference options (ELLIPTA inhaler or BREEZHALER inhaler or No preference).
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be aged 18 years or older at the time of signing the informed consent.
Participants who have a confirmed mild or moderate asthma diagnosis as per Global Initiative for Asthma (GINA), 2020.
Participants must be on asthma maintenance therapy (Inhaled corticosteroids [ICS] or ICS/ Long acting beta 2-agonist [LABA]) for at least 12 weeks prior to study participation.
Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers.
Females who are not pregnant or not planning a pregnancy during the study or not Lactating.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders.
History of hypersensitivity to any components of the study inhaler (e.g., lactose). In addition, participants with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
Historical or current evidence of clinically significant or rapidly progressing or unstable disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.
Drug/alcohol abuse: Participants with a known or suspected alcohol or drug abuse, which in the opinion of the investigator could interfere with the participant's proper completion of the protocol requirement.
A participant will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator, as well as employees of GSK or Novartis.
Inability to Read: In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions.
Medical and physical conditions that in the opinion of the investigator could impact the ability of the participant to manipulate the inhaler.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijverdal
ZIP/Postal Code
7442 LS
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3051 GV
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Citations:
PubMed Identifier
36368290
Citation
van der Palen J, Slade D, Rehal S, Verma M, Plank M. A randomized, cross-over study comparing critical and overall errors, learning time, and preference of the ELLIPTA versus BREEZHALER dry powder inhalers in patients with asthma. Respir Med. 2022 Dec;205:107031. doi: 10.1016/j.rmed.2022.107031. Epub 2022 Oct 28.
Results Reference
derived
Learn more about this trial
A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma
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