Fluticasone propionate aqueous nasal spray: a well-tolerated and effective treatment for children with perennial rhinitis.
A total of 535 children aged 4-11 years with perennial rhinitis were recruited to two double-blind studies performed at 56 centres in eight European countries, Israel, and South Africa. One study compared the efficacy and tolerability of fluticasone propionate aqueous nasal spray (FPANS), at either 100 micrograms once daily (od) or 100 micrograms twice daily (bd), with beclomethasone dipropionate (BDPANS) 200 micrograms bd for 12 weeks in 120 children aged 6-11 years. The second study compared FPANS 100 micrograms od with FPANS 200 micrograms od and placebo for 4 weeks in 415 children aged 4-11 years. Efficacy was determined by means of patient assessments of nasal symptoms of perennial rhinitis and by investigator assessments of symptoms and nasal condition. The symptoms of nasal blockage, on waking and during the day, sneezing, rhinorrhoea, and nasal itching were assessed by the investigator at clinic visits and by the completion of a patient daily diary card. Safety was assessed by collection of adverse event information, routine haematology and biochemistry testing, and monitoring plasma cortisol levels. FPANS demonstrated good control of symptoms at each dose regimen, which was equivalent or superior to BDPANS and superior to placebo. There was no difference between the dose regimens of FPANS. FPANS was as well tolerated as placebo and BDPANS. It is concluded that FPANS 100 micrograms od is an effective and well-tolerated treatment for perennial rhinitis in children aged 4-11 years.
Richards
D H
DH
Glaxo Wellcome Research & Development Ltd, Uxbridge, UK.
Milton
C M
CM
D000336:Aerosols; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
D000336:Aerosols; D000730:Androstadienes; D018926:Anti-Allergic Agents; D000068298:Fluticasone; D006854:Hydrocortisone