Correct usage, ease of use, and preference of two dry powder inhalers in patients with COPD: analysis of five phase III, randomized trials
Authors Riley JH, Tabberer M, Richard N, Donald A, Church A, Harris S
Received 24 March 2016
Accepted for publication 10 June 2016
Published 12 August 2016 Volume 2016:11(1) Pages 1873—1880
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Richard Russell
John H Riley,1 Maggie Tabberer,2 Nathalie Richard,3 Alison Donald,3 Alison Church,3 Stephanie S Harris3
1MDC Global Clinical Development – UK, GlaxoSmithKline, 2Value Evidence and Outcomes, GlaxoSmithKline, Uxbridge, Middlesex, UK; 3Respiratory Medicines Development Center, GlaxoSmithKline, Durham, NC, USA
Background: Handheld inhalers are used to deliver treatment for COPD. Incorrect usage leads to suboptimal disease control. Complex treatment regimens and use of multiple inhalers may reduce patient compliance. The Anoro Ellipta™ dry powder inhaler (DPI) simultaneously delivers umeclidinium bromide (UMEC) and vilanterol (VI) without coformulation being required.
Aim: To assess the correct usage and ease of use of the Ellipta™ DPI administering UMEC/VI and to compare patient preference for Ellipta™ with the HandiHaler® through exploratory analyses of patient and observer questionnaires in five Phase III studies.
Methods: Two Phase III, 3-month double-blind, placebo-controlled studies assessed the correct usage of the Ellipta™ DPI at Day 1 and after 6 weeks, and ease of use of the Ellipta™ DPI using a nonvalidated patient questionnaire after 6 weeks or early withdrawal. In three 6-month, blinded double-dummy, active comparator studies (two Phase IIIa and one Phase IIIb), patients completed a COPD device preference questionnaire between the Ellipta™ DPI and the HandiHaler® at Day 168 (Week 24) or early withdrawal.
Results: In the 3-month placebo-controlled studies, ≥98% of patients used the Ellipta™ DPI correctly and 99% of patients found the inhaler easy/very easy-to-use and the dose counter easy/very easy to read. Across the two Phase IIIa active comparator studies, patients consistently stated a preference for the Ellipta™ DPI over HandiHaler® regarding the number of steps to use (59% vs 17%), time taken to use (62% vs 14%), and ease of use (63% vs 15%) regardless of which inhaler contained active drug. Results were consistent in the Phase IIIb active comparator study.
Conclusion: Delivery of UMEC/VI via the Ellipta™ DPI was considered easy-to-use, and patients with COPD demonstrated clear preference for this inhaler compared with HandiHaler®.
Keywords: ease of use, Ellipta™, inhaler, preference, chronic obstructive pulmonary disease (COPD), umeclidinium/vilanterol