24-hour bronchodilator efficacy of single doses of indacaterol in subjects with COPD: comparison with placebo and formoterol

Curr Med Res Opin. 2009 Feb;25(2):463-70. doi: 10.1185/03007990802675096.

Abstract

Objective: To assess the bronchodilator efficacy, safety and tolerability of indacaterol, a novel, once-daily inhaled beta(2)-agonist bronchodilator, in patients with chronic obstructive pulmonary disease (COPD).

Methods: This crossover, double-blind, double-dummy study was conducted to evaluate the 24-h bronchodilator effect of a range of single doses of indacaterol (150 microg, 300 microg and 600 microg), given in the morning via single-dose dry powder inhaler (SDDPI) in subjects with COPD, compared with placebo and with the daily therapeutic dose of formoterol (two 12 microg doses 12 h apart, via an SDDPI). Tolerability and safety were also assessed.

Results: Fifty-one subjects with moderate-to-severe COPD received each of the five treatments on separate study days in randomised sequence. The 24-h trough FEV(1) (primary endpoint; mean [95% CI]) was 1.46 (1.43, 1.49) L with indacaterol 600 microg (p < 0.001 vs. placebo, p < 0.01 vs. formoterol, p < 0.05 vs. indacaterol 150 microg), 1.45 (1.42, 1.48) L with indacaterol 300 microg (p < 0.001 vs. placebo, p < 0.05 vs. formoterol), 1.42 (1.39, 1.45) L with indacaterol 150 microg (p < 0.001 vs. placebo), 1.41 (1.38, 1.43) L with formoterol (p < 0.001 vs. placebo) and 1.28 (1.25, 1.31) L with placebo. All treatments were well tolerated and there was little effect on serum potassium, blood glucose or QTc interval.

Conclusion: All doses of indacaterol were effective in providing 24-h bronchodilation and were well-tolerated in subjects with COPD. The bronchodilator efficacy of indacaterol (150, 300 and 600 microg) at 24 h post-dose was at least as efficacious as formoterol 12 microg twice daily.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Area Under Curve
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / pharmacokinetics
  • Bronchodilator Agents / therapeutic use*
  • Cross-Over Studies
  • Double-Blind Method
  • Ethanolamines / administration & dosage
  • Ethanolamines / pharmacokinetics
  • Ethanolamines / therapeutic use*
  • Female
  • Forced Expiratory Volume
  • Formoterol Fumarate
  • Humans
  • Indans / administration & dosage
  • Indans / pharmacokinetics
  • Indans / therapeutic use*
  • Male
  • Middle Aged
  • Placebos
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Quinolones / administration & dosage
  • Quinolones / pharmacokinetics
  • Quinolones / therapeutic use*
  • Vital Capacity

Substances

  • Bronchodilator Agents
  • Ethanolamines
  • Indans
  • Placebos
  • Quinolones
  • indacaterol
  • Formoterol Fumarate