Salomon Joerg, Stolz Daiana, Domenighetti Guido, Frey Jean-Georges, Turk Alexander J, Azzola Andrea, Sigrist Thomas, Fitting Jean-William, Schmidt Ulrich, Geiser Thomas, Wild Corinne, Kostikas Konstantinos, Clemens Andreas, Brutsche Martin
Lung Centre Salem-Spital, Bern, Switzerland.
University Hospital Basel, Basel, Switzerland.
Respir Res. 2017 Jan 11;18(1):13. doi: 10.1186/s12931-016-0498-1.
Dual bronchodilator therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD). There are limited data on effects of a combination of two long-acting bronchodilators on lung function including body plethysmography.
This multicentre, randomised, double-blind, single-dose, cross-over, placebo-controlled study evaluated efficacy and safety of the free combination of indacaterol maleate (IND) and glycopyrronium bromide (GLY) versus IND alone on spirometric and body plethysmography parameters, including inspiratory capacity (IC), forced expiratory volume in 1 s (FEV), forced vital capacity (FVC), total lung capacity (TLC) and airway resistance (Raw) in moderate-to-severe COPD patients.
Seventy-eight patients with FEV % pred. (mean ± SD) 56 ± 13% were randomised. The combination of IND + GLY versus IND presented a numerically higher peak-IC (Δ = 0.076 L, 95% confidence interval [CI]: -0.010 - 0.161 L; p = 0.083), with a statistically significant difference in mean IC over 4 h (Δ = 0.054 L, 95%CI 0.022 - 0.086 L; p = 0.001). FEV, FVC and Raw, but not TLC, were consistently significantly improved by IND + GLY compared to IND alone. Safety profiles of both treatments were comparable.
The free combination of IND + GLY improved lung function parameters as evaluated by spirometry and body plethysmography, with a similar safety profile compared to IND alone.
NCT01699685.
对于有症状的慢性阻塞性肺疾病（COPD）患者，推荐使用双重支气管扩张剂治疗。关于两种长效支气管扩张剂联合使用对包括体容积描记法在内的肺功能影响的数据有限。
这项多中心、随机、双盲、单剂量、交叉、安慰剂对照研究评估了马来酸茚达特罗（IND）与格隆溴铵（GLY）的自由组合相对于单独使用IND对中重度COPD患者的肺量计和体容积描记法参数（包括吸气容量（IC）、1秒用力呼气量（FEV）、用力肺活量（FVC）、肺总量（TLC）和气道阻力（Raw））的疗效和安全性。
78例FEV%预计值（均值±标准差）为56±13%的患者被随机分组。IND+GLY组合与IND相比，峰值IC在数值上更高（差值=0.076L，95%置信区间[CI]：-0.010 - 0.161L；p=0.083），4小时内平均IC有统计学显著差异（差值=0.054L，95%CI 0.022 - 0.086L；p=0.001）。与单独使用IND相比，IND+GLY持续显著改善FEV、FVC和Raw，但未改善TLC。两种治疗的安全性相当。
IND+GLY的自由组合改善了通过肺量计和体容积描记法评估的肺功能参数，与单独使用IND相比安全性相似。
NCT01699685。
