LaForce Craig, Taveras Herminia, Iverson Harald, Shore Paul
Allergy Asthma Proc. 2017 Jan 28;38(1):28-37. doi: 10.2500/aap.2017.38.4015.
A novel, inhalation-driven, multidose dry powder inhaler (MDPI) that does not require coordination of actuation with inhalation has been developed.
To evaluate the efficacy and safety of albuterol MDPI versus placebo MDPI after chronic dosing in children with asthma.
This phase III, double-blind, parallel-group study included children with asthma (ages, 4-11 years) with forced expiratory volume in 1 second (FEV1) of 50-95% of predicted. After a 14-day run-in period wherein the patients continued their current asthma therapy and received single-blind placebo MDPI, they were randomized to albuterol MDPI 90 μg per inhalation, two inhalations four times daily (total daily dose, 720 μg), or placebo for 3 weeks. Pulmonary function was assessed on days 1 and 22. Efficacy and safety were evaluated by measuring the baseline-adjusted percent-predicted FEV1 (PPFEV1) area under the time curve over 6 hours (AUC0-6) after the dose and adverse events, respectively.
The full analysis set included 184 patients. Patients treated with albuterol MDPI versus patients treated with placebo MDPI had significantly greater baseline-adjusted PPFEV1 AUC0-6 over 3 weeks (least squares mean difference, 25.0%•hour, which favored albuterol; p < 0.001). The benefit of albuterol (mean change in PPFEV1) was evident 5 minutes after dosing and lasted several hours; the maximal effect was noted 1 to 2 hours after dosing. Albuterol MDPI was well tolerated.
In children with persistent asthma, albuterol MDPI improved pulmonary function significantly better than placebo MDPI over 3 weeks of treatment. Clinical efficacy was evident within 5 minutes of dosing and maintained for >2 hours. Four times daily administration was well tolerated.
已研发出一种新型的、吸入驱动的多剂量干粉吸入器（MDPI），其无需在吸入时协调启动操作。
评估沙丁胺醇MDPI与安慰剂MDPI在哮喘儿童长期给药后的疗效和安全性。
这项III期双盲平行组研究纳入了哮喘儿童（年龄4至11岁），其1秒用力呼气量（FEV1）为预测值的50%至95%。在为期14天的导入期内，患者继续其当前的哮喘治疗并接受单盲安慰剂MDPI，之后他们被随机分为接受每次吸入90μg沙丁胺醇MDPI、每日4次、每次2吸（每日总剂量720μg）或安慰剂治疗3周。在第1天和第22天评估肺功能。分别通过测量给药后6小时内时间曲线下基线调整后的预测FEV1百分比（PPFEV1）面积（AUC0 - 6）和不良事件来评估疗效和安全性。
完整分析集包括184名患者。与接受安慰剂MDPI治疗的患者相比，接受沙丁胺醇MDPI治疗的患者在3周内基线调整后的PPFEV1 AUC0 - 6显著更高（最小二乘均值差异为25.0%•小时，有利于沙丁胺醇；p < 0.001）。沙丁胺醇的益处（PPFEV1的平均变化）在给药后5分钟即明显，且持续数小时；给药后1至2小时达到最大效果。沙丁胺醇MDPI耐受性良好。
在持续性哮喘儿童中，在3周治疗期间，沙丁胺醇MDPI比安慰剂MDPI能显著更好地改善肺功能。给药后5分钟内临床疗效明显，并持续超过2小时。每日4次给药耐受性良好。
