在中度至重度稳定 COPD 成年患者中，以 Discair 干粉吸入递送的 12/400-µg 福莫特罗/布地奈德单剂量组合的支气管扩张剂疗效：开放标签、单臂、IV 期试验。
Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial.
机构信息
University of Health Sciences, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.
Center for Drug Research and Development and Pharmacokinetic Applications (ARGEFAR), Ege University, Izmir, Turkey.
出版信息
Clin Drug Investig. 2019 Oct;39(10):991-1001. doi: 10.1007/s40261-019-00828-y.
BACKGROUND AND OBJECTIVES
A patient-friendly and easy-to-use multi-dose dry powder inhaler, Discair, has been recently developed. The objective of this study was to evaluate the bronchodilator efficacy of a single-dose 12/400-µg formoterol plus budesonide combination as a dry powder for inhalation delivered by Discair in adult patients with moderate-to-severe, stable, chronic obstructive pulmonary disease.
METHODS
A total of 33 male patients with moderate-to-severe, chronic obstructive pulmonary disease were included in this single-arm, open-label, phase IV trial. The primary efficacy parameters were the average maximum change in forced expiratory volume in 1 s (FEV, in L) and time to maximum FEV response. Absolute and percent change from baseline in FEV and forced vital capacity, maximum change and time to peak forced vital capacity response were also evaluated.
RESULTS
The mean post-bronchodilator FEV maximum value was significantly higher than the pre-bronchodilator baseline FEV value [1.66 (standard deviation 0.43) vs. 1.32 (standard deviation 0.35), p < 0.001], with an absolute change of 0.34 (standard deviation 0.18) and a percent change of 26.0 (standard deviation 0.14) from baseline to maximum response. The average time to peak FEV response was 3.94 h (standard deviation 2.75), while the standardized area under the response-time curve from 0 to 12 h for FEV was 2.72 (standard deviation 1.84). The FEV and forced vital capacity values recorded at each time point during the 12-h post-bronchodilator period were also significantly higher than the baseline values (p < 0.001 for each).
CONCLUSIONS
Our findings revealed significant changes from baseline in post-bronchodilator peak and average FEV and forced vital capacity responses, indicating bronchodilator efficacy of a single-dose 12/400 µg formoterol plus budesonide dry powder formulation delivered by Discair in patients with chronic obstructive pulmonary disease.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT03028701.
背景和目的
最近开发了一种患者友好且易于使用的多剂量干粉吸入器 Discair。本研究的目的是评估单剂量 12/400μg 福莫特罗加布地奈德联合干粉吸入器在中重度稳定慢性阻塞性肺疾病患者中的支气管扩张作用。
方法
本项单臂、开放标签、IV 期试验共纳入 33 例男性中重度慢性阻塞性肺疾病患者。主要疗效参数为用力呼气量（FEV）的平均最大变化率和达到最大 FEV 时间。还评估了 FEV 和用力肺活量的绝对和百分比变化、最大变化和达到峰值用力肺活量时间。
结果
支气管扩张剂后 FEV 的平均最大值显著高于支气管扩张剂前的基础 FEV 值[1.66（标准差 0.43）比 1.32（标准差 0.35），p<0.001]，绝对变化为 0.34（标准差 0.18），从基线到最大反应的百分比变化为 26.0（标准差 0.14）。FEV 反应的平均达峰时间为 3.94 h（标准差 2.75），而 FEV 从 0 到 12 h 的反应时间标准化面积为 2.72（标准差 1.84）。支气管扩张剂后 12 h 内每个时间点的 FEV 和用力肺活量值也明显高于基线值（p<0.001）。
结论
我们的研究结果表明，支气管扩张剂后 FEV 和用力肺活量的峰值和平均反应均有显著变化，表明单剂量 12/400μg 福莫特罗加布地奈德干粉制剂在慢性阻塞性肺疾病患者中的支气管扩张作用。
试验注册
ClinicalTrials.gov 标识符 NCT03028701。
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