Publication

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

Calverley, P. M., Eriksson, G., Jenkins, C. R., Anzueto, A. R., Make, B. J., Persson, A., Fageras, M. & Postma, D. S., 19-Dec-2017, In : International Journal of Chronic Obstructive Pulmonary Disease. 12, p. 13-25 13 p.

Research output: Contribution to journalArticleAcademicpeer-review

  • Peter M. Calverley
  • Goran Eriksson
  • Christine R. Jenkins
  • Antonio R. Anzueto
  • Barry J. Make
  • Anders Persson
  • Malin Fageras
  • Dirkje S. Postma

Background and objective: Large clinical trials have confirmed the long-term efficacy of inhaled corticosteroid/long-acting beta(2)-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 mu g or placebo, twice daily; in one study, tiotropium 18 mu g 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.

Original languageEnglish
Pages (from-to)13-25
Number of pages13
JournalInternational Journal of Chronic Obstructive Pulmonary Disease
Volume12
Publication statusPublished - 19-Dec-2017

    Keywords

  • bronchodilator agents, clinical respiratory medicine, clinical trials, COPD, OBSTRUCTIVE PULMONARY-DISEASE, METERED-DOSE INHALER, FLUTICASONE PROPIONATE, CLINICAL-TRIAL, DOUBLE-BLIND, EXACERBATIONS, MANAGEMENT, TIOTROPIUM, FORMOTEROL, BUDESONIDE

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