ELLIPTA dry powder versus metered-dose inhalers in an optimized clinical trial setting.

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. (C) 2019 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.