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Evaluation of the preference, satisfaction and correct use of Breezhaler (R) and Respimat (R) inhalers in patients with chronic obstructive pulmonary disease - INHALATOR study

机译:评估慢性阻塞性肺病患者的Breezhaler(R)和Respimat(R)吸入器的偏好,满意度和正确使用 - 吸入器研究

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摘要

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 (R) and Respimat (R) devices in patients under daily use of open Spiriva (R) or open Onbrize (R), 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 (R) and 135 of Respimat (R). At treatment start, the rate of correct inhaler use was 40.4% (95% CI: 32.2%-48.7%) for Breezhaler (R) and 36.3% (95% CI: 28.2%-44.4%) for Respimat (R) (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 (R) than Respimat (R) and 57.1% preferred using Breezhaler (R) (p= 0.001) while 30.1% preferred Respimat (R) (p 0.001).
机译:吸入器研究是一项随机的多方形,开放标签,每次7天,交叉研究,两天的冲洗,旨在评估Breezhaler(R)和Respimat之间的正确使用,满意度和偏好( r)患者在日常使用Open Spiriva(R)或OpenBrize(R)中的装置,作为单药治疗温和或中度COPD。患者患者和GT; = 40年,吸烟历史至少包括至少10包的历史。主要终点是在读取药物传单信息后在治疗后的第一天使用每个装置的正确使用速率,并在训练有素的评估员的监督下进行评估。在每个治疗阶段结束时,重新评估吸入器使用,并完成满足问卷。在研究结束时评估了吸入器装置的患者的偏好。由于筛查故障引起的排除后,140名患者随机分配:136次以至少一种剂量的Breezhaler(R)和135个Respimat(R)。在治疗开始时,Breezhaler(R)的正确吸入器使用率为40.4%(95%CI:32.2%-48.7%),36.3%(95%CI:28.2%-44.4%)用于respimat(r)(p = 0.451)。 7天后,分别的速率为68.9%(95%CI:61.1%-76.7%)和60.4%(95%CI:52.2%-68.7%)(P = 0.077)。根据与吸入器问卷的满足感,使用Breezhaler(R)比respimat(R)更满意,使用Breezhaler(r)(p = 0.001),57.1%的患者更满意(r)(p = 0.001),而30.1%优选的respimat(r)(p & 0.001)。

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