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Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study.

Abstract：

BACKGROUND: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. METHODS: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 (FEV1), forced vital capacity (FVC), total lung capacity (TLC) and airway resistance (Raw) in moderate-to-severe COPD patients. RESULTS:Seventy-eight patients with FEV1 % 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). FEV1, FVC and Raw, but not TLC, were consistently significantly improved by IND + GLY compared to IND alone. Safety profiles of both treatments were comparable. CONCLUSION: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. TRIAL REGISTRATION:NCT01699685.

journal_name

Respir Res

journal_title

Respiratory research

authors

Salomon J,Stolz D,Domenighetti G,Frey JG,Turk AJ,Azzola A,Sigrist T,Fitting JW,Schmidt U,Geiser T,Wild C,Kostikas K,Clemens A,Brutsche M

doi

10.1186/s12931-016-0498-1

subject

Has Abstract

pub_date

2017-01-11 00:00:00

pages

13

issue

1

eissn

1465-9921

issn

1465-993X

pii

10.1186/s12931-016-0498-1

journal_volume

18

pub_type

杂志文章,多中心研究,随机对照试验

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