Ostrom Nancy K, Raphael Gordon, Tillinghast Jeffrey, Hickey Lisa, Small Calvin J
From the Allergy & Asthma Medical Group & Research Center, San Diego, California, USA.
Bethesda Allergy Asthma and Research Center, L.L.C., Bethesda, Maryland, USA.
Allergy Asthma Proc. 2018 Mar 9;39(2):117-126. doi: 10.2500/aap.2018.39.4115. Epub 2018 Jan 9.
Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standard metered-dose inhalers (MDI).
To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI.
This 6-week, phase III, double-blind study included patients aged ≥12 years with persistent asthma. During the single-blind run-in, patients discontinued asthma medications and received twice-daily placebo BAI or MDI. At randomization, BAI patients received BDP BAI 320 μg/day, BDP BAI 640 μg/day, or placebo BAI, and MDI patients received BDP MDI 320 μg/day or placebo MDI. Assessments included standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from 0 to 6 weeks (AUEC[0-6 wk]) (obtained by clinic-based spirometry; the primary end point), morning peak expiratory flow (PEF), trough daily morning FEV1 (obtained by handheld spirometry), withdrawals, and tolerability.
Of 425 patients randomized, most were white (81%) and female (61%). BDP BAI 320 and 640 μg/day significantly improved FEV1 AUEC(0-6 wk) versus placebo (p < 0.001). The BDP BAI treatment groups exhibited significantly improved morning PEF and daily morning FEV1 versus placebo (p < 0.001). Similar treatment effects were demonstrated for BDP MDI (p < 0.001). Fewer patients withdrew due to worsening asthma while taking BDP BAI 320 μg/day (n = 1), BDP BAI 640 μg/day (n = 0), and BDP MDI 320 μg/day (n = 1) versus placebo (n = 10). BDP BAI was well tolerated.
BDP BAI demonstrated significant improvements in pulmonary function versus placebo, with results similar to BDP MDI. The safety profile of BDP BAI was comparable to BDP MDI, with no new safety signals.The study was registered on ClinicalTrials.gov (NCT02513160), www.clinicaltrials.gov.
呼吸驱动吸入器（BAI）消除了标准定量吸入器（MDI）所需的手 - 呼吸协调需求。
评估通过BAI给予丙酸倍氯米松（BDP）的疗效和安全性。
这项为期6周的III期双盲研究纳入了年龄≥12岁的持续性哮喘患者。在单盲导入期，患者停用哮喘药物，每日接受两次安慰剂BAI或MDI。随机分组时，BAI组患者接受320μg/天的BDP BAI、640μg/天的BDP BAI或安慰剂BAI，MDI组患者接受320μg/天的BDP MDI或安慰剂MDI。评估包括标准化的基线校正后第1秒用力呼气容积（FEV1）、0至6周效应曲线下面积（AUEC[0 - 6周]）（通过基于诊所的肺量计获得；主要终点）、早晨呼气峰值流速（PEF）、每日早晨低谷FEV1（通过手持式肺量计获得）、退出研究情况和耐受性。
在425名随机分组的患者中，大多数为白人（81%）且为女性（61%）。与安慰剂相比，320μg/天和640μg/天的BDP BAI显著改善了FEV1 AUEC(0 - 6周)（p < 0.001）。BDP BAI治疗组与安慰剂相比，早晨PEF和每日早晨FEV1有显著改善（p < 0.001）。BDP MDI也显示出类似的治疗效果（p < 0.001）。与安慰剂组（n = 10）相比，服用320μg/天的BDP BAI（n = 1）、640μg/天的BDP BAI（n = 0）和320μg/天的BDP MDI（n = 1）的患者因哮喘恶化而退出研究的较少。BDP BAI耐受性良好。
与安慰剂相比，BDP BAI在肺功能方面有显著改善，结果与BDP MDI相似。BDP BAI的安全性与BDP MDI相当，没有新的安全信号。该研究已在ClinicalTrials.gov（NCT02513160），www.clinicaltrials.gov上注册。
