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

Rennard, Stephen and Bantje, Theo and Centanni, Stefano and Chanez, Pascal and Chuchalin, Alexander and D'Urzo, Anthony and Kornmann, Oliver and Perry, Sheryl and Jack, Damon and Owen, Roger and Higgins, Mark (2008) A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison. Respiratory Medicine, 102 (7). pp. 1033-1044. ISSN 0954-6111

Abstract

This dose-ranging study assessed the bronchodilator efficacy and tolerability of indacaterol, a novel once-daily inhaled beta2-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 FEV(1)40% of predicted and > or =1.0L; FEV1/FVC <70%) were randomized to receive indacaterol 50, 100, 200 or 400microg or placebo via multi-dose dry powder inhaler, or indacaterol 400microg 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 18microg once daily for 8 days. The primary efficacy variable was the trough bronchodilator effect: standardized area under the FEV1 curve between 22 and 24h post-dose (FEV1 AUC(22-24h)) on Day 1. Clinically relevant improvements versus placebo in FEV1 AUC(22-24h) were seen for 400 and 200microg doses on Day 1 and all doses on Day 7. All indacaterol doses significantly (P<0.05) increased FEV1 from 5min to 24h post-dose; the 400 and 200microg 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 beta2-agonist bronchodilator. Indacaterol demonstrated a good overall safety and tolerability profile.

Item Type: Article
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Additional Information: author can archive post-print (ie final draft post-refereeing); Publisher's version/PDF cannot be used
Keywords: Indacaterol; COPD; Tiotropium; Efficacy; Safety; Dose
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Date Deposited: 14 Dec 2009 13:53
Last Modified: 31 Jan 2013 01:06
URI: https://oak.novartis.com/id/eprint/811

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