title: Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease.
abstract: The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/formoterol (Symbicort) 160/4.5 microg (delivered dose), budesonide 200 microg (metered dose), formoterol 4.5 microg or placebo. Severe exacerbations and FEV1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever beta2-agonist and safety variables were recorded. Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever beta2-agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. All treatments were well tolerated. These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease.
authors.affiliation: Dept Lung Diseases, Voivodeship Specialist Hospital, Radom, Poland.
authors.forename: W
authors.initials: W
authors.lastname: Szafranski
authors.forename: A
authors.initials: A
authors.lastname: Cukier
authors.forename: A
authors.initials: A
authors.lastname: Ramirez
authors.forename: G
authors.initials: G
authors.lastname: Menga
authors.forename: R
authors.initials: R
authors.lastname: Sansores
authors.forename: S
authors.initials: S
authors.lastname: Nahabedian
authors.forename: S
authors.initials: S
authors.lastname: Peterson
authors.forename: H
authors.initials: H
authors.lastname: Olsson
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate