A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison

Stephen Israel Rennard, Theo Bantje, Stefano Centanni, Pascal Chanez, Alexander Chuchalin, Anthony D'Urzo, Oliver Kornmann, Sheryl Perry, Damon Jack, Roger Owen, Mark Higgins

Research output: Contribution to journalArticle

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Abstract

This dose-ranging study assessed the bronchodilator efficacy and tolerability of indacaterol, a novel once-daily inhaled β2-agonist, in subjects clinically diagnosed with COPD. Comparative data with tiotropium were collected. In the double-blind, core period of the study, 635 subjects with COPD (prebronchodilator FEV1≥40% of predicted and ≥1.0 L; FEV1/FVC <70%) were randomized to receive indacaterol 50, 100, 200 or 400 μg or placebo via multi-dose dry powder inhaler, or indacaterol 400 μg via single-dose dry powder inhaler, once daily for 7 days. After completing double-blind treatment and washout, a subset of subjects from each treatment group entered an open-label extension and received tiotropium 18 μg once daily for 8 days. The primary efficacy variable was the trough bronchodilator effect: standardized area under the FEV1 curve between 22 and 24 h post-dose (FEV1 AUC22-24h) on Day 1. Clinically relevant improvements versus placebo in FEV1 AUC22-24h were seen for 400 and 200 μg doses on Day 1 and all doses on Day 7. All indacaterol doses significantly (P<0.05) increased FEV1 from 5 min to 24 h post-dose; the 400 and 200 μg doses were most effective. All doses were well tolerated. Indacaterol trough FEV1 levels compared favorably with the improvement seen by Day 8 in subjects treated with tiotropium in the open-label extension. The results confirm that indacaterol has a 24-h duration of bronchodilator effect and a fast onset of action in COPD and suggest that indacaterol could be an effective once-daily inhaled β2-agonist bronchodilator. Indacaterol demonstrated a good overall safety and tolerability profile.

Original languageEnglish (US)
Pages (from-to)1033-1044
Number of pages12
JournalRespiratory Medicine
Volume102
Issue number7
DOIs
StatePublished - Jul 1 2008

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Bronchodilator Agents
Dry Powder Inhalers
Chronic Obstructive Pulmonary Disease
Placebos
Tiotropium Bromide
indacaterol
Area Under Curve
Safety
Therapeutics

Keywords

  • COPD
  • Dose
  • Efficacy
  • Indacaterol
  • Safety
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Rennard, S. I., Bantje, T., Centanni, S., Chanez, P., Chuchalin, A., D'Urzo, A., ... Higgins, M. (2008). A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respiratory Medicine, 102(7), 1033-1044. https://doi.org/10.1016/j.rmed.2008.02.001

A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. / Rennard, Stephen Israel; Bantje, Theo; Centanni, Stefano; Chanez, Pascal; Chuchalin, Alexander; D'Urzo, Anthony; Kornmann, Oliver; Perry, Sheryl; Jack, Damon; Owen, Roger; Higgins, Mark.

In: Respiratory Medicine, Vol. 102, No. 7, 01.07.2008, p. 1033-1044.

Research output: Contribution to journalArticle

Rennard, SI, Bantje, T, Centanni, S, Chanez, P, Chuchalin, A, D'Urzo, A, Kornmann, O, Perry, S, Jack, D, Owen, R & Higgins, M 2008, 'A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison', Respiratory Medicine, vol. 102, no. 7, pp. 1033-1044. https://doi.org/10.1016/j.rmed.2008.02.001
Rennard SI, Bantje T, Centanni S, Chanez P, Chuchalin A, D'Urzo A et al. A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respiratory Medicine. 2008 Jul 1;102(7):1033-1044. https://doi.org/10.1016/j.rmed.2008.02.001
Rennard, Stephen Israel ; Bantje, Theo ; Centanni, Stefano ; Chanez, Pascal ; Chuchalin, Alexander ; D'Urzo, Anthony ; Kornmann, Oliver ; Perry, Sheryl ; Jack, Damon ; Owen, Roger ; Higgins, Mark. / A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. In: Respiratory Medicine. 2008 ; Vol. 102, No. 7. pp. 1033-1044.
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