Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD
Authors Calverley PM, Eriksson G, Jenkins CR, Anzueto AR, Make BJ, Persson A, Fagerås M, Postma DS
Received 3 June 2016
Accepted for publication 10 October 2016
Published 19 December 2016 Volume 2017:12 Pages 13—25
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Dr Richard Russell
Peter M Calverley,1 Göran Eriksson,2 Christine R Jenkins,3 Antonio R Anzueto,4 Barry J Make,5 Anders Persson,6 Malin Fagerås,6 Dirkje S Postma7
1Pulmonary and Rehabilitation Research Group, University Hospital Aintree, Liverpool, UK; 2Department of Respiratory Medicine and Allergology, University Hospital, Lund, Sweden; 3George Institute for Global Health, The University of Sydney and Concord Clinical School, Sydney, Australia; 4Department of Pulmonary Medicine and Allergology, University of Texas Health Sciences Center and South Texas Veterans’ Health Care System, San Antonio, Texas, 5Division of Pulmonary Sciences and Critical Care Medicine, National Jewish Health, University of Colorado, Denver, Colorado, USA; 6AstraZeneca R&D, Gothenburg, Sweden; 7Department of Pulmonary Medicine and Tuberculosis, GRIAC Research Institute, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Background and objective: Large clinical trials have confirmed the long-term efficacy of inhaled corticosteroid/long-acting β2-agonist combinations in patients with chronic obstructive pulmonary disease (COPD). It was hypothesized that significant treatment effects would already be present within 3 months after the initiation of treatment across a range of clinical outcomes, irrespective of COPD severity.
Methods: Post hoc analysis of 3-month post-randomization outcomes, including exacerbation rates, dropouts, symptoms, reliever use, and lung function, from three studies with similar inclusion criteria of moderate-to-very-severe COPD. Patients (n=1,571) were treated with budesonide/formoterol (B/F) 320/9 µg or placebo, twice daily; in one study, tiotropium 18 µg once daily was also given.
Results: Over the first 3 months of treatment, fewer patients randomized to B/F experienced exacerbations versus the placebo group (111 and 196 patients with ≥1 exacerbation, respectively). This was true in each COPD severity group. Compared with placebo, B/F treatment led to significantly lower 3-month exacerbation rates in the moderate and severe COPD severity groups (46% and 57% reduction, respectively), with a nonsignificant reduction (29%) in very severe COPD. Fewer dropouts occurred among patients treated with B/F versus placebo, this effect being greater with increasing COPD severity. B/F was associated with improved forced expiratory volume in 1 s, morning peak expiratory flow rate, total reliever use, and total symptom score versus placebo.
Conclusion: Treatment with B/F decreased exacerbations in patients with moderate-to-very-severe COPD within 3 months of commencing treatment. This effect was paralleled by improved lung function, less reliever medication use, and fewer symptoms, irrespective of disease severity.
Keywords: bronchodilator agents, clinical respiratory medicine, clinical trials, COPD
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