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

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

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.

Keywords: Body plethysmography; COPD; Glycopyrronium; Indacaterol; Spirometry.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Disposition of patients
Fig. 3
Fig. 3
Improvements in a Peak Inspiratory Capacity (peak-IC) [L] (N = 74) and (b) Mean inspiratory Capacity [L] (N = 77) by IND + GLY versus IND alone
Fig. 4
Fig. 4
a Forced expiratory volume in 1 s (FEV1) [L] over time (ITT population, N = 77); b Forced vital capacity (FVC) [L] (N = 77); c Airway resistance (Raw) [cmH2O/L/s] (N = 77)

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