To assess how adding an inhaled corticosteroid/long-acting β2-agonist combination (ICS/LABA, budesonide/formoterol [BUD/FORM]) to an anticholinergic (tiotropium [TIO]) affects exacerbations in patients with COPD, compared with TIO alone.
660 COPD patients with FEV1 ≤50% of predicted normal, FEV1/VC <70% (both pre-bronchodilator) aged ≥40 years and eligible for ICS/LABA combination therapy were randomized to receive either TIO 18μg qd + BUD/FORM 320/9μg bid or TIO 18μg qd + placebo bid, in a 12-week double-blind, parallel-group, multicenter study (NCT00496470).
A 62% reduction in the mean number of severe exacerbations of COPD was observed in patients who received BUD/FORM added to TIO compared with those who received TIO alone (events/patient/3 months was 0.12 for BUD/FORM added to TIO and 0.33 for TIO alone; rate ratio: 0.38 [95%CI 0.25, 0.57], p<0.001). Overall, patients treated with BUD/FORM added to TIO recorded fewer days with severe COPD exacerbation events compared with patients treated with TIO alone, with 289 and 686 days, respectively, of which 287 and 647 days required oral steroid use. A total of 19 patients (6%) in the BUD/FORM + TIO arm and 38 patients (12%) in the TIO arm required at least one prescribed antibiotic for an exacerbation of COPD.
BUD/FORM added to TIO significantly reduces exacerbation rate and number of exacerbation days compared with TIO alone. Treatment with BUD/FORM added to TIO also results in numerically lower antibiotic use for exacerbations of COPD, compared with TIO alone.
BUD/FORM added to TIO reduces the future risk of severe exacerbations.
Tobias Welte, Grant monies (from industry related sources) The Department of Respiratory Medicine, Hannover Medical School, Germany, has received funding for basic research from AstraZeneca.; Shareholder GE, SP and TP hold shares in AstraZeneca.; Employee GE, SP and TP are full time employees of AstraZeneca.; Consultant fee, speaker bureau, advisory committee, etc. TW has received honoraria for lectures from AstraZeneca and is a member of the national and international advisory boards for AstraZeneca. PH has participated on medical advisory boards for the following companies: Abbott, Actelion, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Nycomed, Pfizer and conducted continuing health education activities for the following companies: Actelion, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Pfizer and has conducted industry-sponsored clinical research trials for the following companies: Actelion, AstraZeneca, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Novartis, Nycomed, Paringenix, Pfizer, ZLB Behring. MM has received honoraria for lecturing from AstraZeneca, Bayer Schering, Boehringer Ingelheim and Pfizer and has received honoraria for consultancy from AstraZeneca, Bayer Schering, Boehringer Ingelheim, Pfizer, GlaxoSmithKline and Nycomed.; No Product/Research Disclosure Information