Inhaler user preference study in COPD patients
Research type
Research Study
Full title
Study 200301: An open-label study of inhaler device attributes investigating critical and overall errors, ease of use, and preference between a number of inhaler devices (ELLIPTA, TURBUHALER, HANDIHALER, BREEZHALER, MDI, and DISKUS/ACCUHALER) in adult subjects with Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
161349
Contact name
Michael Thomas
Contact email
Sponsor organisation
GlaxoSmithKline UK Pharma
Research summary
This study will assess the number of errors made by subjects when using the ELLIPTA inhaler device and one of the other inhaler devices, neither of which have been used by the subject before (i.e., DISKUS, TURBUHALER, HANDIHALER, BREEZHALER and MDI). In addition, ease of use and preference of the inhaler devices will be assessed.
During this single visit study, subjects with COPD, will be allocated to one of five groups and receive the ELLIPTA device and one other device. All the inhaler devices in this study will contain placebo only. Subjects will be able to continue their current COPD and other medications during this study. Baseline assessments will include height, weight, ethnic origin, medical/disease history including family history, COPD history, any additional existing conditions, current health and literacy/reading ability score. Adverse events will be recorded.
Once randomised, subjects will receive either the ELLIPTA device first or one of the other devices. The subjects will be asked to read the patient instruction leaflet then to use it. The number of errors they make during the use of the inhaler device will be recorded. If errors are made, the Healthcare Professional (HCP) will demonstrate the correct use of the inhaler to the subject. The subject will then be asked to demonstrate inhaler use again. Any errors from this attempt will be recorded. In total, the HCP will demonstrate the use of the inhaler up to three times. After completing the process with the first inhaler, the same procedures will be followed for the second inhaler. The time taken to complete the demonstration steps will be recorded.
Afterwards the HCP will ask the subject a number of questions from two questionnaires. One questionnaire will be based on the ‘ease of use’ of the device and the other related to preference.REC name
West of Scotland REC 4
REC reference
14/WS/1055
Date of REC Opinion
11 Sep 2014
REC opinion
Further Information Favourable Opinion