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

Details

• Alternative Title:
  Respir Res
• Personal Author:
  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
• Description:
  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
  
  Electronic supplementary material
  
  The online version of this article (doi:10.1186/s12931-016-0498-1) contains supplementary material, which is available to authorized users.
  
  
• Subjects:
  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 Treatment Outcome

  More +
• Source:
  Respir Res. 18.
• Pubmed ID:
  28077140
• Pubmed Central ID:
  PMC5225517
• Document Type:
  Journal Article
• Funding:
  U17 CE002618/CE/NCIPC CDC HHS/United States
• Place as Subject:
  Switzerland
• Volume:
  18
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:f13431110c449eec2f5512e48745cc20decc2d84181c42ec92e86efb81ff121c
• Download URL:
  https://stacks.cdc.gov/view/cdc/44174/cdc_44174_DS1.pdf
• File Type:
  [PDF - 499.76 KB ]