title: Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT01699685.
authors.affiliation: Lung Centre Salem-Spital, Bern, Switzerland.
authors.forename: Joerg
authors.initials: J
authors.lastname: Salomon
authors.affiliation: University Hospital Basel, Basel, Switzerland.
authors.forename: Daiana
authors.initials: D
authors.lastname: Stolz
authors.affiliation: Regional Hospital La Carità, Locarno, Switzerland.
authors.forename: Guido
authors.initials: G
authors.lastname: Domenighetti
authors.affiliation: Hospital du Valais, Sion, Switzerland.
authors.forename: Jean-Georges
authors.initials: JG
authors.lastname: Frey
authors.affiliation: Hospital, Zürcher Rehazentrum Wald, Wald, Switzerland.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Turk
authors.affiliation: Regional Hospital Civico, Lugano, Switzerland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Azzola
authors.affiliation: Hospital, Klinik Barmelweid, Barmelweid, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Sigrist
authors.affiliation: Lausanne University Hospital, Lausanne, Switzerland.
authors.forename: Jean-William
authors.initials: JW
authors.lastname: Fitting
authors.affiliation: Kliniken Valens, Rehabilitation Centre, Walenstadtberg, St. Gallen, Switzerland.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schmidt
authors.affiliation: University Hospital of Bern, Bern, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Geiser
authors.affiliation: Novartis Pharma Schweiz AG, Rotkreuz, Switzerland.
authors.forename: Corinne
authors.initials: C
authors.lastname: Wild
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Kostikas
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. andreas.clemens@novartis.com.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.affiliation: Cantonal Hospital, St. Gallen, Switzerland.
authors.forename: Martin
authors.initials: M
authors.lastname: Brutsche
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D003936:Diagnosis, Computer-Assisted / Q000379:methods; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006024:Glycopyrrolate / Q000008:administration & dosage*; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage; D015990:Placebo Effect; D010993:Plethysmography, Whole Body / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis* / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage*; D015203:Reproducibility of Results; D012129:Respiratory Function Tests / Q000379:methods; D012680:Sensitivity and Specificity; D013147:Spirometry / Q000379:methods*; D013557:Switzerland; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D004338:Drug Combinations; D007189:Indans; D018727:Muscarinic Antagonists; D015363:Quinolones; C510790:indacaterol; D006024:Glycopyrrolate
keywords: Body plethysmography; COPD; Glycopyrronium; Indacaterol; Spirometry