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Indacaterol, a novel inhaled β2-agonist, provides sustained 24-h bronchodilation in asthma

K. M. Beeh, E. Derom, F. Kanniess, R. Cameron, M. Higgins, A. van As
European Respiratory Journal 2007 29: 871-878; DOI: 10.1183/09031936.00060006
K. M. Beeh
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E. Derom
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F. Kanniess
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R. Cameron
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M. Higgins
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A. van As
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Abstract

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.

  • Asthma
  • bronchodilators
  • forced expiratory volume in one second
  • indacaterol
  • long-acting β2-agonist
  • once-daily

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    Indacaterol, a novel inhaled β2-agonist, provides sustained 24-h bronchodilation in asthma
    K. M. Beeh, E. Derom, F. Kanniess, R. Cameron, M. Higgins, A. van As
    European Respiratory Journal May 2007, 29 (5) 871-878; DOI: 10.1183/09031936.00060006

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    Indacaterol, a novel inhaled β2-agonist, provides sustained 24-h bronchodilation in asthma
    K. M. Beeh, E. Derom, F. Kanniess, R. Cameron, M. Higgins, A. van As
    European Respiratory Journal May 2007, 29 (5) 871-878; DOI: 10.1183/09031936.00060006
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