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 (2017). Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study. Respiratory research, 18(1), p. 13. BioMed Central 10.1186/s12931-016-0498-1
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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.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Pneumology |
UniBE Contributor: |
Azzola, Andrea, Geiser, Thomas (A) |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1465-9921 |
Publisher: |
BioMed Central |
Language: |
English |
Submitter: |
Rahel Holderegger |
Date Deposited: |
27 Nov 2017 08:07 |
Last Modified: |
29 Mar 2023 23:35 |
Publisher DOI: |
10.1186/s12931-016-0498-1 |
PubMed ID: |
28077140 |
Uncontrolled Keywords: |
Body plethysmography COPD Glycopyrronium Indacaterol Spirometry |
BORIS DOI: |
10.7892/boris.106601 |
URI: |
https://boris.unibe.ch/id/eprint/106601 |
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