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Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD—a randomised controlled study
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Details:
  • Pubmed ID:
    28077140
  • Pubmed Central ID:
    PMC5225517
  • 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.

  • Document Type:
  • Collection(s):
  • Funding:
    U17 CE002618/CE/NCIPC CDC HHS/United States
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