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
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
1 other identifier
interventional
114
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started Apr 2021
Shorter than P25 for phase_4 asthma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedStudy Start
First participant enrolled
April 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2021
CompletedResults Posted
Study results publicly available
May 15, 2023
CompletedMay 15, 2023
June 1, 2022
3 months
March 21, 2021
July 5, 2022
July 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1
Secondary Outcomes (12)
Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
Day 1
Percentage of Participants Making at Least One Overall Error After Reading PIL
Day 1
Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
Day 1
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Day 1
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
Day 1
- +7 more secondary outcomes
Study Arms (4)
ELLIPTA/ BREEZHALER/Questionnaire version 1
EXPERIMENTALParticipants 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.
ELLIPTA/ BREEZHALER/Questionnaire version 2
EXPERIMENTALParticipants 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.
BREEZHALER/ ELLIPTA/Questionnaire version 1
EXPERIMENTALParticipants 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.
BREEZHALER/ ELLIPTA/Questionnaire version 2
EXPERIMENTALParticipants 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.
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Investigational Site
Enschede, 7512 KZ, Netherlands
GSK Investigational Site
Nijverdal, 7442 LS, Netherlands
GSK Investigational Site
Rotterdam, 3051 GV, Netherlands
Related Publications (1)
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.
PMID: 36368290DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2021
First Posted
March 24, 2021
Study Start
April 14, 2021
Primary Completion
July 8, 2021
Study Completion
July 8, 2021
Last Updated
May 15, 2023
Results First Posted
May 15, 2023
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
- 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.
IPD for this study will be made available via the Clinical Study Data Request site.