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Original Research: COPD |

Long-term Safety and Efficacy of Indacaterol, a Long-Acting β2-Agonist, in Subjects With COPDIndacaterol Use in Subjects With COPD: A Randomized, Placebo-Controlled Study

Kenneth R. Chapman, MD, FCCP; Stephen I. Rennard, MD, FCCP; Angeli Dogra, MS; Roger Owen, PhD; Cheryl Lassen, MD; Benjamin Kramer, MD; on behalf of the INDORSE Study Investigators
Author and Funding Information

From the Asthma and Airway Centre (Dr Chapman), University Health Network, Toronto Western Hospital and the Department of Medicine (Dr Chapman), University of Toronto, Toronto, ON, Canada; the Department of Pulmonary Critical Care, Allergy and Sleep Medicine (Dr Rennard), University of Nebraska Medical Center, Omaha, NE; Novartis Horsham Research Centre (Drs Owen and Lassen), Horsham, West Sussex, England; and Novartis Pharmaceuticals (Ms Dogra and Dr Kramer), East Hanover, NJ.

Correspondence to: Kenneth R. Chapman, MD, FCCP, Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Rm 7-451 E Wing, 399 Bathurst St, Toronto, ON, M5T 2S8, Canada; e-mail: kchapman@ca.inter.net


Funding/Support: This study was funded by Novartis Pharma AG.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2011 American College of Chest Physicians


Chest. 2011;140(1):68-75. doi:10.1378/chest.10-1830
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Background:  Indacaterol is an inhaled, long-acting β2-agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD.

Methods:  Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]).

Results:  Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P < .05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P < .001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally > 4 units.

Conclusions:  During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes.

Trial registry:  ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov

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