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

ABSTRACT

Objective: To assess the bronchodilator efficacy, safety and tolerability of indacaterol, a novel, once-daily inhaled β₂-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 µg, 300 µg and 600 µg), 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 µg 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 FEV₁ (primary endpoint; mean [95% CI]) was 1.46 (1.43, 1.49) L with indacaterol 600 µg (p < 0.001 vs. placebo, p < 0.01 vs. formoterol, p < 0.05 vs. indacaterol 150 µg), 1.45 (1.42, 1.48) L with indacaterol 300 µg (p < 0.001 vs. placebo, p < 0.05 vs. formoterol), 1.42 (1.39, 1.45) L with indacaterol 150 µg (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 μg) at 24 h post-dose was at least as efficacious as formoterol 12 µg twice daily.

Key words: :

• Chronic obstructive pulmonary disease
• Bronchodilation
• Indacaterol
• Formoterol
• FEV₁
• Single dose

Acknowledgements

Declaration of interest: This study was sponsored by Novartis Pharma AG. R. F., F. D., R. O. and M. H. are all employees of Novartis Pharmaceuticals. V. N. has served as consultant to Boehringer Ingelheim and AstraZeneca. O. B. and B. V. have no financial relationships with any company that may be considered a conflict of interest.

The authors thank Sarah Filcek – medical writer, ACUMED, for help in preparing the manuscript (this support was funded by Novartis).

The authors also thank patients and staff at centres involved in the study, particularly co-investigator Dr Wim Verhaeghe (Pneumologie, Ziekenhuis Henri Serruys AV, Oostende), and the other investigators who participated: Prof Renaud Louis, C.H.U. Sart-Tilman, Liege; Dr J. Aumann, Longziekten, Hasselt; Prof. Marc Decramer, UZ Gasthuisberg, Leuven; Dr Alain Delobbe, CHU Sart-Tilman, Liege; Prof. Eric Derom, UZ Gent, Gent; Dr Eddy Janssens, Longziekten, Genk; Dr Jean-Benoît Martinot, Clinique Sainte-Elisabeth, Namur.

Notes

* Aerolizer is a registered trademark of Novartis Pharma AG, Basel