ELLIPTA Dry Powder Versus Metered-Dose Inhalers in an Optimized Clinical Trial Setting

Abstract

Background: Reduced error rates have been demonstrated with the ELLIPTA inhaler versus other commonly used devices.

Objective: This phase IV, randomized, crossover study evaluated correct use of ELLIPTA compared with 2 commonly prescribed metered-dose inhalers (MDIs) in adults with asthma and optimized inhaler technique.

Methods: The study comprised 2 crossover substudies (ELLIPTA vs MDI-1 and ELLIPTA vs MDI-2). Inhaler use was assessed at the start of each period, following instruction from a health care professional, and after 28 days of use without instruction. Data for each inhaler were pooled within substudies, irrespective of treatment sequence; study objectives were addressed in each substudy. The primary end point, percentage of participants making 0 errors after 28 days of use, was analyzed separately for each substudy using a Mainland-Gart test for each ELLIPTA versus MDI comparison.

Results: Correct use rates after 28 days were higher with ELLIPTA than with MDI-1 and MDI-2 (ELLIPTA vs MDI-1, 96% vs 84%; ELLIPTA vs MDI-2, 98% vs 91%). Among discordant cases, statistically significantly more participants correctly used ELLIPTA but made 1 or more overall error with MDIs than did those who correctly used the MDIs but made 1 or more overall error using ELLIPTA (87% vs 13% in both substudies; P < .001 and P = .007 for ELLIPTA vs MDI-1 and ELLIPTA vs MDI-2, respectively). More participants made multiple device errors with MDIs than with ELLIPTA.

Conclusions: Inhaler technique can be optimized in trial settings. In such settings, ELLIPTA is associated with higher rates of correct use and lower error rates than are MDIs.

Trial registration: ClinicalTrials.gov NCT02794480.

Keywords: Clinical trial; Dry powder inhaler; ELLIPTA; Inhaler errors; Inhaler technique; Inhaler training; Metered-dose inhaler; Optimized technique.

Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.