The INHALATOR study was a randomized, multicentre, open label, two-period of 7 days each, crossover study, with 7 days of washout in-between, aiming to evaluate the correct use, satisfaction and preference between Breezhaler® and Respimat® devices in patients under daily use of open Spiriva® or open Onbrize®, as monotherapy for treatment of mild or moderate COPD. Patients aged ≥40 years with a smoking history of at least 10 pack-year were included in the study. Primary endpoint was the rate of correct use of each device at the first day of treatment after reading the drug leaflet information and was evaluated under the supervision of a trained evaluator. At the end of each treatment phase, the inhaler use was re-evaluated and a satisfaction questionnaire was completed. The patients' preference for the inhaler devices was assessed at the end of the study. After exclusions due to screening failures, 140 patients were randomized: 136 received at least one dose of Breezhaler® and 135 of Respimat®. At treatment start, the rate of correct inhaler use was 40.4% (95%CI: 32.2%-48.7%) for Breezhaler® and 36.3% (95%CI: 28.2%-44.4%) for Respimat® (p = 0.451). After 7 days, the rates were 68.9% (95%CI: 61.1%-76.7%) and 60.4% (95%CI: 52.2%-68.7%), respectively (p = 0.077). According to the Feeling of Satisfaction with Inhaler Questionnaire - FSI 10 patients were more satisfied using Breezhaler® than Respimat® and 57.1% preferred using Breezhaler® (p = 0.001) while 30.1% preferred Respimat® (p < 0.001).
Trial registration: ClinicalTrials.gov NCT01727024.
Keywords: Administration; Chronic obstructive pulmonary disease; Inhaler device; Inhaler preference; Patient preference; Patient satisfaction.
Copyright © 2018. Published by Elsevier Ltd.