中度至极重度慢性阻塞性肺疾病患者的瑞芬那新曲线下面积肺活量测定。

IF 2.7 3区 医学 Q2 RESPIRATORY SYSTEM
William Blake LeMaster, Corey J Witenko, Melinda K Lacy, Ann W Olmsted, Edmund J Moran, Donald A Mahler
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引用次数: 0

摘要

目的:在吸入支气管扩张剂治疗慢性阻塞性肺病(COPD)的临床试验中使用了多种肺功能终点。1秒用力呼气容积(FEV1)是慢性阻塞性肺病试验中常报告的终点,FEV1与时间曲线下面积(FEV1 AUC)可作为补充,它提供了在给药间隔内支气管扩张的持续时间和一致性的信息。雷韦芬那新是一种每日一次的支气管扩张剂,在两项重复的 3 期试验中,用低谷 FEV1 测量,它能显著改善慢性阻塞性肺病患者的肺功能。在此,我们利用这些试验的数据报告了一项 FEV1 AUC 子研究:这项事后分析检查了为期12周的3期重复试验(NCT02459080/NCT02512510)的子研究数据;中度至极重度慢性阻塞性肺病患者按1:1比例随机接受瑞芬那新175微克或安慰剂治疗,每天一次。子研究患者在第1天进行FEV1 AUC0-2h评估,继续用药至第84天的患者还在用药后进行24小时连续肺活量测定,评估FEV1 AUC0-2h、AUC0-12h、AUC12-24h和AUC0-24h:分别有50名和47名患者接受了24小时连续肺活量测定;两组患者的大多数基线特征相同。在服药后第 84 天,罗非那新显示出 24 小时内支气管扩张的持续改善;FEV1 AUC0-2h、AUC0-12h、AUC12-24h 和 AUC0-24h 的最小二乘法平均值与安慰剂的差异分别为 282、220、205 和 212 mL(均为 P 结论:罗非那新与安慰剂的比较结果表明,罗非那新对支气管扩张有持续改善作用:这项子研究分析补充了之前的研究结果,即罗非那新可在 24 小时内提供持续的支气管扩张作用。评估其他补充性 COPD 临床试验终点有助于临床医生做出治疗决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.

Purpose: Several lung function endpoints are utilized in clinical trials of inhaled bronchodilators for chronic obstructive pulmonary disease (COPD). Trough forced expiratory volume in 1 second (FEV1) is a commonly reported endpoint in COPD trials and can be complemented by area under the FEV1 vs time curve (FEV1 AUC), which provides information on duration and consistency of bronchodilation over a dosing interval. Revefenacin, a once-daily bronchodilator, significantly improved lung function in patients with COPD when measured by trough FEV1 in two replicate Phase 3 trials. Here, we report an FEV1 AUC substudy using data from these trials.

Patients and methods: This post hoc analysis examined substudy data from 12-week replicate Phase 3 trials (NCT02459080/NCT02512510); patients with moderate to very severe COPD were randomized 1:1 to revefenacin 175 μg or placebo once daily. The substudy patients had FEV1 AUC0-2h assessed on Day 1, and those who continued to Day 84 also underwent 24-hour serial spirometry postdose where FEV1 AUC0-2h, AUC0-12h, AUC12-24h, and AUC0-24h were evaluated.

Results: Fifty and 47 patients who received revefenacin and placebo underwent 24-hour serial spirometry; most baseline characteristics were aligned between groups. At Day 84 postdose, revefenacin demonstrated sustained improvements in bronchodilation over 24 hours; differences in least squares mean vs placebo were 282, 220, 205, and 212 mL for FEV1 AUC0-2h, AUC0-12h, AUC12-24h, and AUC0-24h (all P <0.001), respectively.

Conclusion: This substudy analysis supplements previous findings that revefenacin provides sustained bronchodilation over 24 hours. Assessing additional complementary COPD clinical trial endpoints can help clinicians make treatment decisions.

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来源期刊
CiteScore
4.80
自引率
10.70%
发文量
372
审稿时长
16 weeks
期刊介绍: An international, peer-reviewed journal of therapeutics and pharmacology focusing on concise rapid reporting of clinical studies and reviews in COPD. Special focus will be given to the pathophysiological processes underlying the disease, intervention programs, patient focused education, and self management protocols. This journal is directed at specialists and healthcare professionals
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