title: Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial.
abstract: OBJECTIVE
  To assess the effect of montelukast versus salmeterol added to inhaled fluticasone propionate on asthma exacerbation in patients whose symptoms are inadequately controlled with fluticasone alone. Design and setting A 52 week, two period, double blind, multicentre trial during which patients whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol.
  
  
  METHODS
  Patients (15-72 years; n = 1490) had a clinical history of chronic asthma for > or = 1 year, a baseline forced expiratory volume in one second (FEV1) value 50-90% predicted, and a beta agonist improvement of > or = 12% in FEV1.
  
  
  METHODS
  The primary end point was the percentage of patients with at least one asthma exacerbation.
  
  
  RESULTS
  20.1% of the patients in the group receiving montelukast and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol and fluticasone; the difference was 1% (95% confidence interval -3.1% to 5.0%). With a risk ratio (montelukast-fluticasone/salmeterol-fluticasone) of 1.05 (0.86 to 1.29), treatment with montelukast and fluticasone was shown to be non-inferior to treatment with salmeterol and fluticasone. Salmeterol and fluticasone significantly increased FEV1 before a beta agonist was used and morning peak expiratory flow compared with montelukast and fluticasone (P < or = 0.001), whereas FEV1 after a beta agonist was used and improvements in asthma specific quality of life and nocturnal awakenings were similar between the groups. Montelukast and fluticasone significantly (P = 0.011) reduced peripheral blood eosinophil counts compared with salmeterol and fluticasone. Both treatments were generally well tolerated.
  
  
  CONCLUSIONS
  The addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol.
authors.affiliation: Department of Respiratory Medicine and Allergology, University Hospital, SE-221 85 Lund, Sweden.
authors.forename: Leif
authors.initials: L
authors.lastname: Bjermer
authors.forename: Hans
authors.initials: H
authors.lastname: Bisgaard
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.forename: Leonardo M
authors.initials: LM
authors.lastname: Fabbri
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Greening
authors.forename: Tari
authors.initials: T
authors.lastname: Haahtela
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Holgate
authors.forename: Cesar
authors.initials: C
authors.lastname: Picado
authors.forename: Joris
authors.initials: J
authors.lastname: Menten
authors.forename: S Balachandra
authors.initials: SB
authors.lastname: Dass
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Leff
authors.forename: Peter G
authors.initials: PG
authors.lastname: Polos
mesh_terms: D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000503:physiopathology / Q000517:prevention & control*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008875:Middle Aged; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000068299:Salmeterol Xinafoate; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; C093875:montelukast; D000420:Albuterol