Asthma
Conditions
Interventions
inhalation of a placebo from a dry powder inhaler
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants who make at least one critical error in each inhaler (ELLIPTA or BREEZHALER) after reading the section on inhaler use in the PIL(s). | — |
Secondary
| Measure | Time frame |
|---|---|
| Participants who still make at least one critical error after receiving further instruction (up to 3) from the HCP. Participants receive further instruction if an error was made after reading the PIL. Participants who make at least one overall error after reading the PIL(s) (Attempt 1). This will be repeated for the participants who still make at least one overall error after receiving further instruction (up to 3) from the HCP. Participants receive further instruction if an error was made after reading the PIL. Errors (critical and overall) made after reading the PIL(s), and, if necessary, after receiving further instruction from the HCP. The amount of time taken to demonstrate inhaler use without HCP intervention. The amount of time taken to be given instruction by the HCP (up to 3 times) on use of the inhaler and to demonstrate inhaler use. Ease-of-use preference from questionnaire, that is, how the ease of use is rated (very easy, easy, neutral, difficult or very difficult). The variables will include the: * Variable: Ease of use rating. * Population-summary measure: the number and percentage of participants who rate the inhaler. The population-summary measure defined above will be the same for the following variables as indicated by participants* ease of use: * Telling how many doses are left in Inhaler * Learning how to use the inhaler * Handling the inhaler * Preparing the inhaler * Holding the inhaler while using it Willingness to continue with the inhaler using a visual analogue scale (VAS) between 0 (not willing) to 100 (definitely willing). Participants who expressed a preference on attributes from the preference questionnaire. The number and percentage of participants who prefer the respective inhaler overall (ELLIPTA, BREEZHALER or no preference). | — |
Countries
Netherlands
Outcome results
None listed