Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-Universität Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany.
7th Respiratory Medicine Department, Athens Chest Hospital Sotiria, Athens, Greece.
Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.
Dual bronchodilation combining a long-acting β-agonist (LABA) and a long-acting muscarinic antagonist (LAMA) is the preferred choice of treatment recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 guidelines for the management of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The once-daily (q.d.) fixed-dose combination (FDC) of LABA, indacaterol 110 μg and LAMA, glycopyrronium 50 μg (IND/GLY 110/50 μg q.d.) demonstrated superior improvements in lung function, dyspnoea and overall health status and better tolerability against LABA or LAMA monotherapies and combination of LABA and inhaled corticosteroid (ICS) in more than 11,000 patients with moderate-to-severe COPD in several randomised controlled clinical trials.
The CRYSTAL study was the first, 12-week, randomised, open-label trial that evaluated the efficacy and safety of a direct switch from previous treatments to IND/GLY 110/50 μg q.d. on lung function and dyspnoea in patients with moderate COPD and a history of up to one exacerbation in the previous year. Patients were divided into 2 groups according to their background therapy and symptom scores and were randomised (3:1) to IND/GLY or to continue with their previous treatments.
The study included 4389 randomised patients, of whom 2160 were in groups switched to IND/GLY (intention-to-treat population). The effect of IND/GLY was superior to LABA + ICS on trough forced expiratory volume in 1 s (FEV; treatment difference, Δ = +71 mL) and transition dyspnoea index (TDI; [Δ = 1.09 units]), and to LABA or LAMA on trough FEV (Δ = +101 mL) and a TDI (Δ = 1.26 units). Improvements in health status and lower rescue medication use were also observed with IND/GLY. The safety profile of the study medication was similar to that observed in previous studies.
IND/GLY demonstrated superior improvements in lung function and dyspnoea after direct switch from previous treatments.
ClinicalTrials.gov number: NCT01985334 .
长效β激动剂（LABA）和长效抗胆碱能药物（LAMA）联合的双重支气管扩张作用是 2017 年全球慢性阻塞性肺疾病倡议（GOLD）管理中重度慢性阻塞性肺疾病（COPD）患者的首选治疗方法。每日一次（q.d.）固定剂量联合制剂（LABA，茚达特罗 110μg；LAMA，格隆溴铵 50μg，IND/GLY 110/50μg q.d.）在超过 11000 名中重度 COPD 患者中，与 LABA 或 LAMA 单药治疗以及 LABA 和吸入性皮质类固醇（ICS）联合治疗相比，在肺功能、呼吸困难和整体健康状况方面显示出更好的改善，且耐受性更好。
CRYSTAL 研究是首个 12 周、随机、开放标签试验，评估了中重度 COPD 患者直接从先前治疗转换为 IND/GLY 110/50μg q.d.对肺功能和呼吸困难的疗效和安全性，这些患者在过去一年中有过一次或多次加重史。根据背景治疗和症状评分，患者分为两组，然后随机（3:1）分为 IND/GLY 组或继续接受先前的治疗。
这项研究纳入了 4389 名随机患者，其中 2160 名患者被纳入接受 IND/GLY 治疗的组（意向治疗人群）。IND/GLY 的疗效优于 LABA+ICS（治疗差异为+71mL）和呼吸困难转移指数（TDI；[Δ=1.09 单位]），也优于 LABA 或 LAMA（治疗差异为+101mL）和 TDI（治疗差异为+1.26 单位）。IND/GLY 还可改善健康状况和减少急救药物的使用。研究药物的安全性与之前研究中观察到的安全性相似。
IND/GLY 可直接从先前的治疗中转换后，显著改善肺功能和呼吸困难。
ClinicalTrials.gov 编号：NCT01985334。
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