Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark.
Thorax. 2010 Jun;65(6):473-9. doi: 10.1136/thx.2009.125435.
Indacaterol is a long-acting inhaled beta(2)-agonist (LABA) for the treatment of chronic obstructive pulmonary disease (COPD). In previous studies, indacaterol provided 24 h bronchodilation on once-daily dosing with a fast onset of action. This study compared the efficacy and safety of indacaterol with the twice-daily LABA formoterol and placebo over 1 year.
Patients with moderate to severe COPD were randomised to receive once-daily indacaterol 300 microg (n=437) or 600 microg (n=428), twice-daily formoterol 12 microg (n=435) or placebo (n=432) for 52 weeks in a double-blind double-dummy parallel group study. The primary efficacy variable was forced expiratory volume in 1 s (FEV(1)) measured 24 h postdose after 12 weeks (indacaterol vs placebo). Other outcomes included dyspnoea (transition dyspnoea index, TDI), use of as-needed salbutamol, symptom-based measures recorded on diary cards, exacerbations, health status (St George's Respiratory Questionnaire), BODE index (body mass index, obstruction, dyspnoea, exercise), safety and tolerability.
Indacaterol increased 24 h postdose FEV(1) after 12 weeks by 170 ml (both doses) versus placebo and by 100 ml versus formoterol (all p<0.001). These significant differences were maintained at 52 weeks. Symptomatic outcomes were improved compared with placebo with all active treatments, and indacaterol was more effective than formoterol in improving TDI score and reducing the need for as-needed salbutamol. Indacaterol was well tolerated and had a good overall safety profile, including minimal impact on QTc interval and systemic beta(2)-mediated events.
Once-daily indacaterol is an effective 24 h bronchodilator that improves symptoms and health status and confers clinical improvements over a twice-daily 12 h LABA as a treatment for patients with moderate to severe COPD.
NCT 00393458.
茚达特罗是一种长效吸入性β2-受体激动剂（LABA），用于治疗慢性阻塞性肺疾病（COPD）。在之前的研究中，茚达特罗在每日一次给药时提供 24 小时支气管扩张作用，起效迅速。这项研究比较了茚达特罗每日一次与每日两次 LABA 福莫特罗和安慰剂治疗一年的疗效和安全性。
中度至重度 COPD 患者被随机分配接受每日一次茚达特罗 300μg（n=437）或 600μg（n=428）、每日两次福莫特罗 12μg（n=435）或安慰剂（n=432）治疗 52 周，采用双盲双模拟平行组研究。主要疗效变量是 12 周后 24 小时剂量后测量的 1 秒用力呼气量（FEV1）（茚达特罗与安慰剂比较）。其他结果包括呼吸困难（过渡呼吸困难指数，TDI）、按需沙丁胺醇使用、日记卡记录的基于症状的测量、恶化、健康状况（圣乔治呼吸问卷）、BODE 指数（体重指数、阻塞、呼吸困难、运动）、安全性和耐受性。
茚达特罗在 12 周后增加了 24 小时剂量后 FEV1，与安慰剂相比增加了 170ml（两种剂量），与福莫特罗相比增加了 100ml（均<0.001）。这些显著差异在 52 周时仍保持。与安慰剂相比，所有活性治疗均改善了症状性结局，茚达特罗在改善 TDI 评分和减少按需沙丁胺醇使用方面比福莫特罗更有效。茚达特罗耐受性良好，具有良好的总体安全性，包括对 QTc 间隔和全身β2 介导事件的影响最小。
每日一次茚达特罗是一种有效的 24 小时支气管扩张剂，可改善症状和健康状况，并为中重度 COPD 患者提供优于每日两次 12 小时 LABA 的临床改善。
NCT 00393458。
