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Effect of indacaterol on dynamic lung hyperinflation and breathlessness in patients with COPD

beeh, kai, wagner, frank, Khindri, Sanjeev and Drollmann, Anton Franz (2011) Effect of indacaterol on dynamic lung hyperinflation and breathlessness in patients with COPD. COPD, 8 (5). pp. 340-345. ISSN 1541-2555

Abstract

Abstract
Indacaterol is a novel, inhaled once-daily ultra long-acting β2-agonist for the treatment of COPD. This randomised, double-blind, placebo-controlled, two-period crossover study evaluated the effect of two-week treatment with indacaterol 300 μg on peak- and isotime exercise inspiratory capacity (IC) in patients with COPD. Patients (40–80 years) with post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <70%, percent predicted FEV1 ≥40% and ≤80%, smoking history ≥20 pack-years and functional residual capacity >120% of predicted normal were randomised to receive indacaterol 300 μg or placebo once-daily via a single-dose dry powder inhaler. Following 14 days of treatment, IC at peak- and isotime during constant-load (80% of maximum workload) cycle ergometry was analysed using linear mixed-effects models. Safety and tolerability were also monitored.
Twenty-seven patients (67% male; mean age, 61.3 years) were randomised; 24 completed the study. On Day 14, indacaterol showed statistically significant improvements over placebo in peak (317 [95% CI: 118–517]; p=0.0033) and isotime IC (268 mL [95% CI: 104–432]; p=0.0026). Statistically significant improvements were observed with indacaterol versus placebo on Day 14 for the following secondary endpoints: resting IC, FEV1, dyspnoea (BDI/TDI and Borg CR10 scale) and exercise endurance time. Indacaterol was well tolerated, with no serious adverse events or deaths.
In conclusion, indacaterol 300 μg administered once-daily showed a clinically relevant increase in IC after 14 days of treatment, reflecting a reduction in dynamic hyperinflation.

Item Type: Article
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Additional Information: author can archive post-print (ie final draft post-refereeing); Restrictions: 12 month embargo for STM, Behavioural Science and Public Health Journals 18 month embargo for SSH journals
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Date Deposited: 13 Oct 2015 13:15
Last Modified: 13 Oct 2015 13:15
URI: https://oak.novartis.com/id/eprint/3894

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