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Author Bjermer, L.; Bisgaard, H.; Bousquet, J.; Fabbri, L.M.; Greening, A.P.; Haahtela, T.; Holgate, S.T.; Picado, C.; Menten, J.; Dass, S.B.; Leff, J.A.; Polos, P.G. url  doi
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  Title Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial Type Journal Article
  Year (down) 2003 Publication BMJ Abbreviated Journal BMJ  
  Volume 327 Issue 7420 Pages 891  
  Keywords Acetates/*administration & dosage/adverse effects; Adolescent; Adult; Aged; Albuterol/*administration & dosage/adverse effects/*analogs & derivatives; Androstadienes/*administration & dosage/adverse effects; Anti-Asthmatic Agents/*administration & dosage/adverse effects; Asthma/physiopathology/*prevention & control; Bronchodilator Agents/*administration & dosage/adverse effects; Double-Blind Method; Drug Therapy, Combination; Fluticasone; Forced Expiratory Volume/drug effects; Humans; Middle Aged; Quinolines/*administration & dosage/adverse effects; Salmeterol Xinafoate; Treatment Outcome  
  Abstract OBJECTIVES: 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. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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. CONCLUSION: The addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol.  
  Address Department of Respiratory Medicine and Allergology, University Hospital, SE-221 85 Lund, Sweden  
  Corporate Author Thesis  
  Impact Factor 17,445 First Author Bjermer, L. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Polos, P.G.  
  ISSN 0959-535X ISBN Medium  
  Area Expedition Conference  
  Notes PMID:14563743; PMCID:PMC218809 Approved no  
  Call Number Serial 165  
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