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 2017 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. application/pdf https://sonar.ch/global/documents/185108 eng info:eu-repo/semantics/altIdentifier/doi/10.1186/s12931-016-0498-1 info:eu-repo/semantics/altIdentifier/pmid/28077140 info:eu-repo/semantics/openAccess 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 Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study. http://purl.org/coar/resource_type/c_6501