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Indacaterol, a novel inhaled ß₂-agonist, provides sustained 24-h bronchodilation in asthma

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

CORRESPONDENCE: K. M. Beeh, insaf Respiratory Research Institute, Biebricher Allee 34, D-65187 Wiesbaden, Germany. Fax: 49 6119854348. E-mail: k.beeh{at}insaf-wi.de

Keywords: Asthma, bronchodilators, forced expiratory volume in one second, indacaterol, long-acting ß₂-agonist, once-daily

Received: May 5, 2006
Accepted January 7, 2007

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

In the present double-blind crossover study, 42 patients were randomised to receive single doses of indacaterol (50, 100, 200 and 400 µg) or placebo via a hydrofluoroalkane pressurised metered-dose inhaler. The primary efficacy comparisons were the per cent changes in forced expiratory volume in one second (FEV₁ ) between indacaterol and placebo 30 min and 21 h 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 7.6 and 14.9%, respectively, at 30 min, and 7.5 and 10.4%, respectively, at 21 h post-dose. At these doses, changes in mean FEV₁ relative to placebo were statistically significant from 5 min to 25 h, inclusive. At 5 min, 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. At 24 h after dosing, the baseline-adjusted geometric least square mean FEV₁ was 3.13, 3.11, 3.24 and 3.30 L for indacaterol 50, 100, 200 and 400 µg, respectively, and 2.98 L for placebo. All treatments were well tolerated.

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

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