title: Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations.
abstract: This randomised, double-blind, 6-month study compared budesonide/formoterol for maintenance and relief with salmeterol/fluticasone and a fixed maintenance dose of budesonide/formoterol, both with terbutaline for relief. Following a 2-week run-in, 3335 symptomatic adults and adolescents (mean FEV1 73% predicted, mean inhaled corticosteroid dose 745 microg/day) received budesonide/formoterol 160/4.5 microg one inhalation bid plus additional inhalations as needed, salmeterol/fluticasone 25/125 microg two inhalations bid plus as-needed terbutaline or budesonide/formoterol 320/9 microg one inhalation bid plus as-needed terbutaline. Budesonide/formoterol for maintenance and relief prolonged the time to first severe exacerbation requiring hospitalisation, emergency room treatment or oral steroids (primary variable) vs. fixed-dose salmeterol/fluticasone and budesonide/formoterol (p=0.0034 and p=0.023 respectively; log-rank test). Exacerbation rates were 19, 16 and 12 events/100 patients/6 months for salmeterol/fluticasone, fixed-dose budesonide/formoterol and budesonide/formoterol for maintenance and relief, respectively, [rate reduction vs. fixed-dose salmeterol/fluticasone (0.61; 95% CI 0.49-0.76, p<0.001) and vs. fixed-dose budesonide/formoterol (0.72; 95% CI 0.57-0.90, p=0.0048)]. Budesonide/formoterol maintenance and relief patients used less inhaled corticosteroid vs. salmeterol/fluticasone and fixed-dose budesonide/formoterol patients. All treatments provided similar marked improvements in lung function, asthma control days and asthma-related quality of life. Budesonide/formoterol for maintenance and relief reduces asthma exacerbations and maintains similar daily asthma control at a lower overall drug load compared with fixed-dose salmeterol/fluticasone and budesonide/formoterol.
authors.affiliation: Department of Pneumonology and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland. pkuna@bg.p@lodz.pl
authors.forename: P
authors.initials: P
authors.lastname: Kuna
authors.forename: M J
authors.initials: MJ
authors.lastname: Peters
authors.forename: A I
authors.initials: AI
authors.lastname: Manjra
authors.forename: C
authors.initials: C
authors.lastname: Jorup
authors.forename: I P
authors.initials: IP
authors.lastname: Naya
authors.forename: N E
authors.initials: NE
authors.lastname: Martínez-Jimenez
authors.forename: R
authors.initials: R
authors.lastname: Buhl
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D019819:Budesonide / Q000627:therapeutic use*; D004311:Double-Blind Method; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate