Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Toronto, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada.
Department of Pulmonary Critical Care, Allergy and Sleep Medicine, University of Nebraska Medical Center, Omaha, NE.
Chest. 2011 Jul;140(1):68-75. doi: 10.1378/chest.10-1830. Epub 2011 Feb 24.
Indacaterol is an inhaled, long-acting β(2)-agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD.
Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV(1) at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]).
Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV(1) relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P < .05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P < .001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally > 4 units.
During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes.
ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov.
茚达特罗是一种吸入性长效β2 受体激动剂，每日一次给药可提供 24 小时支气管扩张作用，用于治疗 COPD 患者。
完成了一项为期 26 周的随机、双盲研究的中重度 COPD 患者，如符合条件可参与一项扩展研究，在该研究中继续接受双盲茚达特罗 150μg 或 300μg 每日一次或安慰剂治疗 26 周。主要目的是评估茚达特罗的长期安全性。疗效终点包括第 52 周时（给药后 24 小时）的谷值（最低值）FEV1、恶化情况和健康状况（圣乔治呼吸问卷[SGRQ]）。
415 名患者参与了扩展研究。分别有 76%、77%和 68%的接受茚达特罗 150μg、茚达特罗 300μg 和安慰剂治疗的患者出现了不良反应，大多数为轻度或中度。分别有 10.4%、12.3%和 10.5%的患者出现了严重不良事件。茚达特罗对心电图（校正 QT 间期）或血清钾或血浆葡萄糖水平无明显临床影响。在整个研究过程中，与安慰剂相比，茚达特罗可增加谷值 FEV1（第 52 周时≥170mL）。未发现对其支气管扩张作用的耐受性。茚达特罗治疗可显著减少 COPD 恶化（与安慰剂相比，发生率比值为 0.62-0.64；P<.05），减少按需使用沙丁胺醇（减少 1.2-1.4 吸/d，与安慰剂相比，P<.001）。与安慰剂相比，使用茚达特罗治疗后健康状况得到改善，平均总 SGRQ 评分的基线降低通常>4 分。
在 1 年的治疗期间，茚达特罗具有良好的耐受性，并可提供显著且持久的支气管扩张作用，同时改善临床结局。
ClinicalTrials.gov；编号：NCT00677807；网址：www.clinicaltrials.gov。
