Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma.
Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma.
复制标题
通过呼吸驱动吸入器输送二丙酸倍氯米松（80 和 160 微克/天）治疗持续性哮喘的评估。
DOI：
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发表时间：
2017
影响因子：
2.8
通讯作者：
C. Small
中科院分区：
文献类型：
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作者：
F. Hampel;W. Carr;M. Gillespie;C. Small
背景
呼吸驱动式吸入器（BAI）与其他装置相比可以简化吸入药物的输送。
目的
评价二丙酸倍氯米松BAI与匹配安慰剂在青少年和成人持续性哮喘患者中的疗效和安全性。
方法
这项为期12周的III期双盲研究招募了年龄≥12岁的哮喘患者，这些患者此前曾接受过稳定剂量的吸入性皮质类固醇或非皮质类固醇治疗。经过14至21天的导入期后，患者以1：1：1的比例随机分配至二丙酸倍氯米松BAI 80或160微克/天（40或80微克，每日两次）或安慰剂BAI。主要终点为0 - 12周标准化基线校正的1秒晨用力呼气量谷值（FEV 1）效应曲线下面积（AUEC[0-12周]）。次要终点包括最大呼气流量、急救药物的使用、哮喘症状和因符合哮喘恶化的预定标准而停药的时间。其他终点评价了生活质量、使用说明和安全性。
结果
全分析集和安全性集分别包括270例和273例患者。与安慰剂相比，接受二丙酸倍氯米松BAI 80或160 μ g/天治疗的患者FEV 1 AUEC（0-12周）显著改善（p ≤ 0.001）。与安慰剂相比，接受二丙酸倍氯米松BAI 80或160微克/天的患者次要终点的改善也很明显。在第12周，接受二丙酸倍氯米松BAI 80或160微克/天治疗的患者的哮喘生活质量问卷评分较安慰剂组增加更大。在参加预防用药子研究的98例患者中，87例（88.8%）在首次尝试时成功使用了吸入器。治疗通常是安全的，耐受性良好。
结论
二丙酸倍氯米松BAI 80和160微克/天是哮喘患者有效且被广泛接受的治疗方法，其安全性与通过定量吸入器递送的二丙酸倍氯米松相当。
BACKGROUND
Breath-actuated inhalers (BAI) may simplify the delivery of inhaled medications compared with other devices.
OBJECTIVE
To evaluate the efficacy and safety of beclomethasone dipropionate BAI versus matching placebo in adolescent and adult patients with persistent asthma.
METHODS
This phase III, 12-week, double-blind study enrolled patients with asthma aged ≥12 years who were previously treated with a stable dose of inhaled corticosteroid or noncorticosteroid therapy. After a run-in period of 14 to 21 days, patients were randomly assigned in a 1:1:1 ratio to beclomethasone dipropionate BAI 80 or 160 micrograms/day (40 or 80 micrograms twice daily) or placebo BAI. The primary end point was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 12 weeks (AUEC[0-12 weeks]). Secondary end points included peak expiratory flow, rescue medication use, asthma symptoms, and the time to withdrawal due to meeting predefined criteria for worsening asthma. Additional end points evaluated quality of life, instructions for use, and safety.
RESULTS
The full analysis and the safety sets included 270 and 273 patients, respectively. Patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day had significant improvements in FEV1 AUEC(0-12 weeks) versus placebo (p ≤ 0.001). Improvements in secondary end points were also apparent in patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day compared with placebo. Patients who received beclomethasone dipropionate BAI 80 or 160 micrograms/day had greater increases in Asthma Quality of Life Questionnaire scores versus placebo patients at week 12. Of 98 patients who participated in the instructions-for-use substudy, 87 (88.8%) used the inhaler successfully on their first attempt. Treatment was generally safe and well tolerated.
CONCLUSION
Beclomethasone dipropionate BAI 80 and 160 micrograms/day were effective and well-accepted treatments in patients with asthma, with safety comparable to beclomethasone dipropionate delivered via a metered-dose inhaler.Clinical trial NCT02040779, www.clinicaltrials.gov.