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

Calverley, Peter M.; Eriksson, Göran LU ; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Persson, Anders; Fagerås, Malin and Postma, Dirkje S. (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.

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author
organization
publishing date
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 Press
external identifiers
  • scopus:85007576477
  • wos:000390378200001
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
2018-01-07 11:45:15
@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},
  keyword      = {Bronchodilator agents,Clinical respiratory medicine,Clinical trials,COPD},
  language     = {eng},
  pages        = {13--25},
  publisher    = {Dove Press},
  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},
  volume       = {12},
  year         = {2017},
}