Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD\u2014a randomised controlled study

Joerg Salomon,Thomas Sigrist,Martin Brutsche,Konstantinos Kostikas,Daiana Stolz,Andreas Clemens,Corinne Wild,Alexander J Turk,Thomas Geiser,Jean-Georges Frey,Guido Domenighetti,Andrea Azzola,Jean-William Fitting,Ulrich Schmidt

doi:10.1186/s12931-016-0498-1

Abstract

BackgroundDual 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.MethodsThis 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.ResultsSeventy-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.ConclusionThe 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 registrationNCT01699685

Highlights

Dual bronchodilator therapy is recommended for symptomatic patients with chronic obstructive pulmonary disease (COPD)
In this study we evaluated the efficacy and safety of the free combination of indacaterol maleate (IND) + glycopyrronium bromide (GLY) versus IND alone on lung function parameters evaluated by body plethysmography, including inspiratory capacity (IC), forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), total lung capacity (TLC) and airway resistance (Raw), in patients with moderate-to-severe COPD
A statistically significant adjusted treatment difference in FEV1 was noted at all time points in favour of IND + GLY treatment (p

Summary

Introduction

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. Static lung hyperinflation is one of the significant challenges in patients with COPD. Since LABAs and LAMAs have different mechanisms of action, they may exert additive bronchodilation effects when used together This suggests that IND and GLY could be used in combination to optimise and maximise bronchodilation in patients with COPD whose needs are not adequately met by LABA or LAMA monotherapy [8,9,10]. There are limited data on the effects of a combination of two long-acting bronchodilators on body plethysmography lung function parameters in patients with COPD [11]

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Results

Discussion

Conclusion