Preference and Ease of Use Inhaler Study
Research type
Research Study
Full title
A randomised, open label, two-period, cross-over, multi-centre study to compare correct inhaler handling of fluticasone/ formoterol breath-actuated inhaler (K-Haler®) with that of Symbicort® Turbohaler® in subjects with persistent asthma, ACOS or COPD.
IRAS ID
169720
Contact name
Lucielle Mansfield
Contact email
Sponsor organisation
Mundipharma Research Limited
Eudract number
2014-004564-38
Duration of Study in the UK
1 years, 2 months, 7 days
Research summary
This is a randomised, open label, crossover patient handling study in male and female subjects with asthma-chronic obstructive pulmonary disease (COPD) Overlap Syndrome (ACOS) or COPD to compare a test inhaler with a marketed inhaler. It is a multicentre study to be carried out in the UK and Germany and enrolling up to approximately 368 subjects in total.
Eligible subjects aged 18 and over will be trained and assessed in the correct handling of two devices and site staff (upon subject questioning) will complete four questionnaires: inhaler device history questionnaire, inhaler training history questionnaire, ease of use and preference questionnaire and the patient preference of device questionnaire.
A spirometer will be used to assess FEV1, FVC/FEV6.
The study will consist of six visits: Screening visit = visit 1. Four assessment visits (visits two to five) and a follow up visit (visit 6). Subjects who meet the criteria will be randomised to a treatment sequence in which they will receive the test and then the reference treatment each over a 12 week period instead of their own inhaler.
Each treatment period will be separated by a 21 day wash out period, during which time the subjects will use their own (prestudy) inhalers. A 14 day follow up period concludes the study. The total study duration for each subject will be a maximum of 236 days.
REC name
HSC REC A
REC reference
15/NI/0049
Date of REC Opinion
14 Apr 2015
REC opinion
Further Information Favourable Opinion