Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study.
- Salomon J Lung Centre Salem-Spital, Bern, Switzerland.
- Stolz D University Hospital Basel, Basel, Switzerland.
- Domenighetti G Regional Hospital La Carità, Locarno, Switzerland.
- Frey JG Hospital du Valais, Sion, Switzerland.
- Turk AJ Hospital, Zürcher Rehazentrum Wald, Wald, Switzerland.
- Azzola A Regional Hospital Civico, Lugano, Switzerland.
- Sigrist T Hospital, Klinik Barmelweid, Barmelweid, Switzerland.
- Fitting JW Lausanne University Hospital, Lausanne, Switzerland.
- Schmidt U Kliniken Valens, Rehabilitation Centre, Walenstadtberg, St. Gallen, Switzerland.
- Geiser T University Hospital of Bern, Bern, Switzerland.
- Wild C Novartis Pharma Schweiz AG, Rotkreuz, Switzerland.
- Kostikas K Novartis Pharma AG, Basel, Switzerland.
- Clemens A Novartis Pharma AG, Basel, Switzerland. andreas.clemens@novartis.com.
- Brutsche M Cantonal Hospital, St. Gallen, Switzerland.
- 2017-01-13
Published in:
- Respiratory research. - 2017
Body plethysmography
COPD
Glycopyrronium
Indacaterol
Spirometry
Adrenergic beta-2 Receptor Agonists
Adult
Aged
Aged, 80 and over
Cross-Over Studies
Diagnosis, Computer-Assisted
Double-Blind Method
Drug Combinations
Female
Glycopyrrolate
Humans
Indans
Male
Middle Aged
Muscarinic Antagonists
Placebo Effect
Plethysmography, Whole Body
Pulmonary Disease, Chronic Obstructive
Quinolones
Reproducibility of Results
Respiratory Function Tests
Sensitivity and Specificity
Spirometry
Switzerland
Treatment Outcome
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12931-016-0498-1
- PMID 28077140
- Persistent URL
- https://sonar.ch/global/documents/185108
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