ELLIPTA Vs combined Inhalers in COPD patients
Research type
Research Study
Full title
A randomized, open-label, cross-over, placebo-device study investigating critical and over all errors, training/teaching time, and preference attributes of the ELLIPTA dry powder Inhaler (DPI) as compared to HandiHaler DPI used in combination with either DISKUS DPI or Turbuhaler DPI, in adult patients with Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
216583
Contact name
David Collier
Contact email
Sponsor organisation
GlaxoSmithKline UK pharma
Duration of Study in the UK
0 years, 5 months, 18 days
Research summary
The study, conducted by GSK, will compare critical errors, training time, and patient preference for closed triple therapy received from a single ELLIPTA inhaler versus open triple therapy received from HandiHaler in combination with either DISKUS or Turbuhaler in subjects with chronic obstructive pulmonary disease (COPD). These comparisons will be performed as separate sub studies
Sub-study 1: Will compare ELLIPTA dry powder inhaler (DPI) to DISKUS-HandiHaler DPI combination
Sub-study 2: Will compare ELLIPTA DPI to Turbuhaler-HandiHaler DPI combination.The study has 2 visits (V0 and V1) which can be completed on the same day.
Once randomised, subjects will use the ELLIPTA inhaler followed by 2 other inhalers or start with the 2 other inhalers followed by the ELLIPTA inhaler. All the inhalers will only contain placebo. Subjects will continue their current COPD and other medications. Assessments will include height, weight, ethnic origin, medical, family and COPD history, current health and reading ability score.
Subjects will be asked to read the patient instruction leaflet then to use the inhaler. The number of errors made while using the inhaler will be recorded. If errors are made, the Healthcare Professional (HCP) will demonstrate the correct use of the inhaler. Subject will then be asked to demonstrate inhaler use again. Any errors from this attempt will be recorded. The HCP will demonstrate the use of the inhaler up to 2 times. After completing the process with the first inhaler, the same procedures will be followed for the second and third inhaler. The time taken to complete the demonstration steps will also be recorded. Adverse events will be recorded.
Afterwards the HCP will ask the subject a number of questions.
The study will be conducted in the UK and The Netherlands. A total of 160 subjects will be included, 80 of them in the UK.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0496
Date of REC Opinion
16 Dec 2016
REC opinion
Further Information Favourable Opinion