Indacaterol, a novel inhaled ₂-agonist, provides sustained 24-hour bronchodilation in asthma

¹ insaf Respiratory Research Institute, Wiesbaden, Germany
² Dept of Respiratory Diseases, Ghent University Hospital, Ghent, Belgium
³ Pulmonary Research Institute, Hospital Grosshansdorf, Hamburg, Germany
⁴ Novartis Horsham Research Centre, Horsham, UK
⁵ Pulmonary and Critical Care Medicine, Drexel University College of Medicine, Philadelphia, USA

^* To whom correspondence should be addressed. E-mail: k.beeh{at}insaf-wi.de.

	Abstract

This study examined the bronchodilator and safety profiles of single-dose indacaterol in intermittent or persistent asthma.

In this double-blind crossover study, 42 patients were randomised to receive single doses of indacaterol (50, 100, 200, 400 µg) or placebo, via HFA pMDI. The primary efficacy comparisons were the % changes in FEV₁ between indacaterol and placebo 30 minutes and 21 hours post-dose.

All doses resulted in prolonged bronchodilation, with indacaterol 200 and 400 µg meeting pre-specified efficacy criteria. The mean percentage increases in FEV₁ from placebo with indacaterol 200 and 400 µg were, respectively, 7.6% and 14.9% at 30 minutes, and 7.5% and 10.4% at 21 hours post-dose. At these doses, relative to placebo, changes in mean FEV₁ were statistically significant (p<0.05) from 5 minutes to 25 hours, inclusive. At 5 minutes, the geometric least squares mean values for FEV₁ were 3.08 and 3.22 L for the 200 and 400 µg doses, respectively, compared with 2.99 L for placebo (both p<0.05). At 24 hours after dosing, the baseline-adjusted geometric least square mean FEV₁ was 3.13, 3.11, 3.24 and 3.30L for indacaterol 50, 100, 200 and 400µg, respectively, and 2.98L for placebo. All treatments were well tolerated.

Once-daily indacaterol at doses of 200 and 400 µg provided sustained 24-hour bronchodilation, with a rapid onset, and a good tolerability and safety profile.

Keywords:  Asthma, bronchodilators, FEV₁, indacaterol, long-acting ₂-agonist, once-daily, QAB149

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