Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD.



Calverley, Peter M, Eriksson, Göran, Jenkins, Christine R, Anzueto, Antonio R, Make, Barry J, Persson, Anders, Fagerås, Malin and Postma, Dirkje S
(2017) Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD. International journal of chronic obstructive pulmonary disease, 12. 13 - 25.

[img] Text
Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD.pdf - Published Version

Download (754kB) | Preview

Abstract

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.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.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.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.

Item Type: Article
Uncontrolled Keywords: Lung, Humans, Pulmonary Disease, Chronic Obstructive, Disease Progression, Bronchodilator Agents, Glucocorticoids, Vital Capacity, Forced Expiratory Volume, Treatment Outcome, Administration, Inhalation, Severity of Illness Index, Recovery of Function, Time Factors, Aged, Middle Aged, Patient Dropouts, Female, Male, Adrenergic beta-2 Receptor Agonists, Budesonide, Formoterol Fumarate Drug Combination
Depositing User: Symplectic Admin
Date Deposited: 08 Aug 2019 13:34
Last Modified: 31 Mar 2020 18:10
DOI: 10.2147/COPD.S114209
URI: http://livrepository.liverpool.ac.uk/id/eprint/3051292