title: Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Pulmonary and Rehabilitation Research Group, University Hospital Aintree, Liverpool, UK.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Calverley
authors.affiliation: Department of Respiratory Medicine and Allergology, University Hospital, Lund, Sweden.
authors.forename: Göran
authors.initials: G
authors.lastname: Eriksson
authors.affiliation: George Institute for Global Health, The University of Sydney and Concord Clinical School, Sydney, Australia.
authors.forename: Christine R
authors.initials: CR
authors.lastname: Jenkins
authors.affiliation: Department of Pulmonary Medicine and Allergology, University of Texas Health Sciences Center and South Texas Veterans' Health Care System, San Antonio, Texas.
authors.forename: Antonio R
authors.initials: AR
authors.lastname: Anzueto
authors.affiliation: Division of Pulmonary Sciences and Critical Care Medicine, National Jewish Health, University of Colorado, Denver, Colorado, USA.
authors.forename: Barry J
authors.initials: BJ
authors.lastname: Make
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Persson
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Malin
authors.initials: M
authors.lastname: Fagerås
authors.affiliation: Department of Pulmonary Medicine and Tuberculosis, GRIAC Research Institute, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
authors.forename: Dirkje S
authors.initials: DS
authors.lastname: Postma
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D005260:Female; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D020127:Recovery of Function; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D005938:Glucocorticoids
keywords: COPD; bronchodilator agents; clinical respiratory medicine; clinical trials