Ferguson Gary T, Taylor Angel Fowler, Thach Chau, Wang Qian, Schubert-Tennigkeit Agnes A, Patalano Francesco, Banerji Donald
Pulmonary Research Institute of Southeast Michigan-Farmington Hills.
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Chronic Obstr Pulm Dis. 2016 Aug 18;3(4):716-728. doi: 10.15326/jcopdf.3.4.2016.0131.
The objective of the FLIGHT3 study was to evaluate the long-term safety and efficacy of indacaterol/glycopyrrolate* (IND/GLY) versus an active comparator, IND, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) over 52 weeks. FLIGHT3 was a multicenter, randomized, double-blind, parallel-group, 52-week study. Patients were randomized (1:1:1) to IND/GLY (27.5/15.6 or 27.5/31.2 µg twice daily [b.i.d.]) or IND (75 µg once daily [o.d.]), delivered via the Neohaler device. The primary objective was to evaluate the long-term safety and tolerability of IND/GLY versus IND in terms of adverse event (AE)-reporting rates in patients with moderate-to-severe COPD over 52 weeks. The secondary objective was to evaluate the long-term efficacy of IND/GLY versus IND in terms of pre-dose trough forced expiratory volume in 1 second (FEV) and post-dose 1-h FEV over 52 weeks. A total of 85.2% patients completed the study treatment. The overall incidence of AEs (and SAEs) was similar between treatments. Major adverse cardiovascular events (MACE) and/or cardiovascular (CV) events were comparable between treatment groups. The rate of discontinuation of the study treatment due to AEs was lower for IND/GLY than IND. Improvements in pre-dose trough FEV and post-dose 1-h FEV were consistently superior with IND/GLY than with IND over 52 weeks, demonstrating long-term maintenance of lung function. IND/GLY demonstrated a favorable long-term safety and tolerability profile and provided effective bronchodilation, with maintenance of lung function over 52 weeks in patients with moderate-to-severe COPD. These data support the safety and efficacy of IND/GLY as a treatment option for COPD. ClinTrials.gov identifier NCT01682863 *.
FLIGHT3研究的目的是在52周内，评估茚达特罗/格隆溴铵*（IND/GLY）与活性对照药IND相比，用于中重度慢性阻塞性肺疾病（COPD）患者的长期安全性和有效性。FLIGHT3是一项多中心、随机、双盲、平行组、为期52周的研究。患者被随机分配（1:1:1）接受IND/GLY（27.5/15.6或27.5/31.2微克，每日两次[b.i.d.]）或IND（75微克，每日一次[o.d.]），通过Neohaler装置给药。主要目的是根据中重度COPD患者在52周内的不良事件（AE）报告率，评估IND/GLY与IND相比的长期安全性和耐受性。次要目的是根据给药前1秒用力呼气容积（FEV）谷值和给药后1小时FEV，评估IND/GLY与IND相比在52周内的长期疗效。共有85.2%的患者完成了研究治疗。各治疗组之间AE（和严重不良事件[SAE]）的总体发生率相似。主要不良心血管事件（MACE）和/或心血管（CV）事件在各治疗组之间相当。因AE导致研究治疗停药的发生率，IND/GLY低于IND。在52周内，IND/GLY给药前FEV谷值和给药后1小时FEV的改善始终优于IND，表明肺功能得到长期维持。IND/GLY显示出良好的长期安全性和耐受性，提供有效的支气管扩张作用，在中重度COPD患者中维持肺功能达52周。这些数据支持IND/GLY作为COPD治疗选择的安全性和有效性。临床试验.gov标识符NCT01682863 *
