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Author Bisgaard, H.; Flores-Nunez, A.; Goh, A.; Azimi, P.; Halkas, A.; Malice, M.-P.; Marchal, J.-L.; Dass, S.B.; Reiss, T.F.; Knorr, B.A. url  doi
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  Title Study of montelukast for the treatment of respiratory symptoms of post-respiratory syncytial virus bronchiolitis in children Type Journal Article
  Year (down) 2008 Publication American Journal of Respiratory and Critical Care Medicine Abbreviated Journal Am J Respir Crit Care Med  
  Volume 178 Issue 8 Pages 854-860  
  Keywords Acetates/administration & dosage/*therapeutic use; Bronchiolitis/diagnosis/*drug therapy/virology; Child, Preschool; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Infant; Leukotriene Antagonists/administration & dosage/*therapeutic use; Male; Pilot Projects; Quinolines/administration & dosage/*therapeutic use; Respiratory Syncytial Virus Infections/diagnosis/*drug therapy/virology; Respiratory Syncytial Viruses/*isolation & purification; Retrospective Studies; Severity of Illness Index; Treatment Outcome  
  Abstract RATIONALE: A pilot study (Bisgaard H; Study Group on Montelukast and Respiratory Syncytial Virus. A randomized trial of montelukast in respiratory syncytial virus postbronchiolitis. Am J Respir Crit Care Med 2003;167:379-383) reported the efficacy of montelukast in post-respiratory syncytial virus (RSV) bronchiolitic respiratory symptoms. OBJECTIVES: To evaluate the efficacy and safety of montelukast, 4 and 8 mg, in treating recurrent respiratory symptoms of post-RSV bronchiolitis in children in a large, multicenter study. METHODS: This was a double-blind study of 3- to 24-month-old children who had been hospitalized for a first or second episode of physician-diagnosed RSV bronchiolitis and who tested positive for RSV. Patients (n = 979) were randomized to placebo or to montelukast at 4 or 8 mg/day for 4 weeks (period I) and 20 weeks (period II). The primary end point was percentage symptom-free days (%SFD; day with no daytime cough, wheeze, and shortness of breath, and no nighttime cough). MEASUREMENTS AND MAIN RESULTS: No significant differences were seen between montelukast and placebo in %SFD over period I: mean +/- SD for placebo and for montelukast at 4 and 8 mg were 37.0 +/- 30.7, 38.6 +/- 30.4, and 38.5 +/- 29.9, respectively. Least-squares mean differences (95% confidence interval) between montelukast (4 mg) and placebo and between montelukast (8 mg) and placebo were 1.9% (-2.9, 6.7) and 1.6% (-3.2, 6.5), respectively. Secondary end points were similar across treatments. Both doses were generally well tolerated. During the first two treatment weeks, average %SFD was approximately 29%. In post hoc analyses of patients (n = 523) with persistent symptoms (%SFD < or = 30% over Weeks 1-2), differences in %SFD were seen between montelukast and placebo over Weeks 3-24: difference were 5.7 (0.0, 11.3) for montelukast (4 mg) minus placebo and 5.9 (0.1, 11.7) for montelukast (8 mg) minus placebo. CONCLUSIONS: In this study, montelukast did not improve respiratory symptoms of post-RSV bronchiolitis in children.  
  Address Danish Pediatric Asthma Center, Department of Pediatrics, Copenhagen University Hospital, Gentofte, DK-2900 Copenhagen, Denmark. bisgaard@copsac.dk  
  Corporate Author Thesis  
  Impact Factor 12,996 First Author Bisgaard, H. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Knorr, B.A.  
  ISSN 1073-449X ISBN Medium  
  Area Expedition Conference  
  Notes PMID:18583576 Approved no  
  Call Number Serial 127  
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