ELLIPTA Versus DISKUS plus HandiHaler in COPD: A Randomized, Open-Label, Crossover Study in a Clinical Trial Setting

Abstract

Background: Inhaler errors among patients with chronic obstructive pulmonary disease (COPD) can reduce treatment efficacy.

Methods: This randomized, open-label, crossover study evaluated correct use of ELLIPTA versus DISKUS plus HandiHaler. Participants with COPD attended at least 3 study visits (Day 1 [Visit 1], Day 28 [Visit 2], and Day 56 [Visit 3]). Inhalers contained placebo; usual maintenance medication was continued. Participants were randomized to an inhaler sequence (ELLIPTA then DISKUS plus HandiHaler, or the reverse) and preference questionnaire at Visit 1. Participants read the instructions for use in the approved prescribing information for their inhaler(s) and correct use was assessed at Visit 1 (verbal guidance provided if required). Correct use was reassessed at Visit 2, and with the next inhaler(s) at Visit 3. Primary endpoint was the proportion of participants demonstrating correct use (0 errors) with the assigned inhaler(s) after 28 days.

Results: A greater proportion of study participants (n = 217) correctly used ELLIPTA (96%) versus DISKUS plus HandiHaler (87%) after 28 days. The odds of demonstrating correct use with ELLIPTA were 6.88 times that of DISKUS plus HandiHaler (p < 0.001). Overall, > 99% of participants made 0 critical errors (errors leading to no or significantly reduced medication inhaled) with ELLIPTA versus 89% with DISKUS plus HandiHaler after 28 days. ELLIPTA was the patient-preferred option versus DISKUS plus HandiHaler or no preference (p < 0.001).

Conclusions: Delivery of COPD maintenance therapy via ELLIPTA demonstrates higher correct use rates and lower critical error rates compared with DISKUS plus HandiHaler.

Keywords: DISKUS; ELLIPTA; HandiHaler; copd; correct use; patient preference.

Conflict of interest statement

EMK has participated in consulting, advisory boards, speaker panels, or received travel reimbursement from Amphastar, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline plc., Mylan, Novartis, Oriel, Pearl, Sunovion, Teva, and Theravance. He has conducted multicenter clinical research trials for approximately 40 pharmaceutical companies. SS has been a principal investigator for 20 years and has conducted clinical research trials for a large number of pharmaceutical companies. He has also participated as a consultant and on advisory boards and speaker panels for pharmaceutical companies including AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline plc., Mylan, Menlo, Novartis, Pearl, Sunovion, Teva, and Theravance. MZ, VM, RJ, KC, and RS are employees of, and own shares in, GlaxoSmithKline plc. Editorial support (in the form of writing assistance, collating author comments, assembling tables and/or figures, grammatical editing, fact checking, and referencing) was provided by Matthew Hallam, MSc(Res) and Joanna Wilson, PhD, of Gardine—Caldwell Communications (Macclesfield, UK) and was funded by GlaxoSmithKline plc. Trademarks are the property of their respective owners.

JCOPDF © 2020.

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