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Author Bisgaard, H.; Allen, D.; Milanowski, J.; Kalev, I.; Willits, L.; Davies, P. url  openurl
  Title Twelve-month safety and efficacy of inhaled fluticasone propionate in children aged 1 to 3 years with recurrent wheezing Type Journal Article
  Year (down) 2004 Publication Pediatrics Abbreviated Journal Pediatrics  
  Volume 113 Issue 2 Pages e87-94  
  Keywords Administration, Inhalation; Androstadienes/adverse effects/pharmacology/*therapeutic use; Anti-Asthmatic Agents/pharmacology/therapeutic use; Asthma/*drug therapy; Bronchodilator Agents/adverse effects/pharmacology/*therapeutic use; Cataract/chemically induced; Child, Preschool; Cromolyn Sodium/pharmacology/therapeutic use; Female; Fluticasone; Growth/*drug effects; Humans; Hydrocortisone/blood/urine; Infant; Male; Respiratory Sounds/*drug effects; Treatment Outcome  
  Abstract OBJECTIVE: Our aim was to compare the 12-month safety and efficacy of fluticasone propionate (FP) and sodium cromoglycate (SCG) in children aged 1 to 3 years with mild to moderate recurrent wheeze. METHODS: The study was a randomized, parallel-group, open-label multicenter study of 625 children, aged 1 to 3 years, with recurrent wheeze randomized in a 3:1 ratio to treatment for 52 weeks with FP (100 microg twice daily) via metered-dose inhaler and Babyhaler spacer device or SCG (5 mg 4 times daily) via metered-dose inhaler and Nebuhaler spacer device, respectively. RESULTS: There was no significant difference in mean adjusted growth rates between the 2 groups: 84.0 mm/year in the FP group versus 86.4 mm/year in the SCG group (difference FP-SCG: -2.4 mm/year; 95% confidence interval: -6.6 to 1.8). Growth comparisons were independent of age, gender, previous use of steroid, or whether measured as length and/or height. Serum and urinary cortisol concentrations showed a statistically significant suppression of 10% and 14%, respectively, but the number of patients with serum cortisol levels below the lower normal limit was reduced during the trial. Both treatments were well tolerated. The most common drug-related adverse events were cough (2% FP vs 1% SCG) and hoarseness (1% FP vs 0% SCG). One incident of cataract was observed at baseline and 1 after FP treatment; the latter had resolved after 12 months. The efficacy of FP was superior to SCG with fewer cases of symptom worsening, exacerbations, and requirements for oral steroid treatment and more symptom-free days and days without use of rescue treatment. CONCLUSIONS: Twelve months of treatment with inhaled FP (100 microg twice daily) in preschool children aged 1 to 3 years with recurrent wheeze has no effect on growth and no other clinically important side effects but is more efficacious than SCG.  
  Address Department of Pediatrics, Copenhagen University Hospital, Copenhagen, Denmark. Bisgaard@copsac.dk  
  Corporate Author Thesis  
  Impact Factor 05,473 First Author Bisgaard, H. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Davies, P.  
  ISSN 0031-4005 ISBN Medium  
  Area Expedition Conference  
  Notes PMID:14754977 Approved no  
  Call Number Serial 168  
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