Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD
(2017) In International Journal of COPD 12. p.13-25- Abstract
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... (More)
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.
(Less)
- author
- Calverley, Peter M. ; Eriksson, Göran LU ; Jenkins, Christine R. ; Anzueto, Antonio R. ; Make, Barry J. ; Persson, Anders ; Fagerås, Malin and Postma, Dirkje S.
- organization
- publishing date
- 2017
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Bronchodilator agents, Clinical respiratory medicine, Clinical trials, COPD
- in
- International Journal of COPD
- volume
- 12
- pages
- 13 pages
- publisher
- Dove Medical Press Ltd.
- external identifiers
-
- pmid:28031707
- wos:000390378200001
- scopus:85007576477
- ISSN
- 1176-9106
- DOI
- 10.2147/COPD.S114209
- language
- English
- LU publication?
- yes
- id
- 1ad2440b-6aff-428a-bffb-2dad47dc51c4
- date added to LUP
- 2017-01-16 10:44:02
- date last changed
- 2025-01-25 21:25:16
@article{1ad2440b-6aff-428a-bffb-2dad47dc51c4,
abstract = {{<p>Background and objective: Large clinical trials have confirmed the long-term efficacy of inhaled corticosteroid/long-acting β<sub>2</sub>-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.</p>}},
author = {{Calverley, Peter M. and Eriksson, Göran and Jenkins, Christine R. and Anzueto, Antonio R. and Make, Barry J. and Persson, Anders and Fagerås, Malin and Postma, Dirkje S.}},
issn = {{1176-9106}},
keywords = {{Bronchodilator agents; Clinical respiratory medicine; Clinical trials; COPD}},
language = {{eng}},
pages = {{13--25}},
publisher = {{Dove Medical Press Ltd.}},
series = {{International Journal of COPD}},
title = {{Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD}},
url = {{http://dx.doi.org/10.2147/COPD.S114209}},
doi = {{10.2147/COPD.S114209}},
volume = {{12}},
year = {{2017}},
}