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
Status and phase
Completed
Phase 4
Conditions
Asthma
Treatments
Device: ELLIPTA
Device: BREEZHALER
Details and patient eligibility
About
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.
Enrollment
114 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
114 participants in 4 patient groups
ELLIPTA/ BREEZHALER/Questionnaire version 1
Experimental group
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.
Treatment:
Device: ELLIPTA
Device: BREEZHALER
ELLIPTA/ BREEZHALER/Questionnaire version 2
Experimental group
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.
Treatment:
Device: ELLIPTA
Device: BREEZHALER
BREEZHALER/ ELLIPTA/Questionnaire version 1
Experimental group
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.
Treatment:
Device: ELLIPTA
Device: BREEZHALER
BREEZHALER/ ELLIPTA/Questionnaire version 2
Experimental group
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.
Treatment:
Device: ELLIPTA
Device: BREEZHALER
Trial contacts and locations
3
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems