Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Author(s): Jones PW, Mahler DA, Gale R, Owen R, Kramer B
Affiliation(s): Division of Clinical Science, St George's University of London, Cranmer Terrace, London SW17 0RE, UK. firstname.lastname@example.org
Publication date & source: 2011-06, Respir Med., 105(6):892-9. Epub 2011 Mar 11.
Publication type: Randomized Controlled Trial
BACKGROUND: Indacaterol is a novel, inhaled, ultra-long-acting beta(2)-agonist bronchodilator for maintenance use in patients with COPD. The aim of this paper is to assess the effect of indacaterol on dyspnoea and health status, using pooled study data to evaluate the relative efficacy of indacaterol and existing bronchodilators. METHODS: Individual patient data were pooled from three randomized, placebo-controlled studies (NCT00393458; NCT00567996; NCT00463567), conducted in patients with moderate-to-severe COPD. Treatments were double-blind indacaterol 150 mug (n = 746) or 300 mug (n = 853) once-daily, formoterol 12 mug twice-daily (n = 556), salmeterol 50 mug twice-daily (n = 333) and placebo (n = 1185); and open-label tiotropium 18 mug once-daily (n = 415). Evaluation after 6 months' treatment was by transition dyspnoea index (TDI; minimum clinically important difference [MCID] >/=1 point), and St George's Respiratory Questionnaire (SGRQ; MCID >/=4 units). RESULTS: Differences from placebo in TDI total score were 1.01 (indacaterol 150 mug) 1.28 (indacaterol 300 mug), 0.74 (formoterol), 0.92 (salmeterol) and 0.88 (tiotropium) (all p < 0.05), with corresponding odds ratios versus placebo for exceeding the MCID from baseline of 1.91, 2.69, 2.02, 1.79 and 1.49 (all p < 0.05). Differences versus placebo in SGRQ total score were -4.4 (indacaterol 150 mug), -3.4 (indacaterol 300 mug), -2.8 (formoterol), -4.0 (salmeterol) and -1.7 (tiotropium) (all p < 0.05), with corresponding odds ratios versus placebo for exceeding the MCID of 1.95, 1.63, 1.54, 1.82 and 1.29 (all p < 0.05 apart from tiotropium). CONCLUSIONS: Indacaterol provided clinically important improvements in dyspnoea and health status that were at least as good as and often better than those observed with existing bronchodilator treatments for COPD. Copyright (c) 2011 Elsevier Ltd. All rights reserved.