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 inhalers, in adult participants with mild to moderate asthma.
- Conditions
- Asthmadry powder inhaler10038716
- Registration Number
- NL-OMON50806
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 114
Participant must be aged 18 years or older
Participants who have a confirmed mild or moderate asthma diagnosis
Participants must be on asthma maintenance therapy (ICS or ICS/LABA) for at
least 12 weeks prior to study participation.
Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers
Concurrent diagnosis of COPD or other respiratory disorders including active
tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
pulmonary hypertension, interstitial lung diseases or other active pulmonary
diseases.
History of hypersensitivity to any components of the study inhaler (e.g.,
lactose).
Historical or current evidence of clinically significant or rapidly progressing
or unstable disease that 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.
Participants with a known or suspected alcohol or drug abuse.
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 could impact the ability of the
participant to manipulate the inhaler
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of participants who make at least one critical error in each<br /><br>inhaler (ELLIPTA or BREEZHALER) after reading the section on inhaler use in the<br /><br>PIL(s).</p><br>
- Secondary Outcome Measures
Name Time Method