A PLACEBO-CONTROLLED TRIAL OF FLUTICASONE PROPIONATE IN ASTHMATIC-CHILDREN

Citation
Ca. Mackenzie et al., A PLACEBO-CONTROLLED TRIAL OF FLUTICASONE PROPIONATE IN ASTHMATIC-CHILDREN, European journal of pediatrics, 152(10), 1993, pp. 856-860
Citations number
14
Categorie Soggetti
Pediatrics
ISSN journal
03406199
Volume
152
Issue
10
Year of publication
1993
Pages
856 - 860
Database
ISI
SICI code
0340-6199(1993)152:10<856:APTOFP>2.0.ZU;2-Y
Abstract
Fluticasone propionate is a synthetic steroid for use by the inhaled r oute. It's high topical potency and low systemic bioavailability make it suitable for use in asthmatic children. A total of 258 children wer e randomised in a double-blind study to receive fluticasone propionate (50 mug bd) as the dry powder formulation inhaled via a Diskhaler inh aler, or matched placebo (with current therapy) for 4 weeks throughout which time diary cards were completed. During clinic visits lung func tion and adrenal function were measured. Fluticasone propionate produc ed a significantly greater increase in morning peak expiratory flow ra te (PEFR) (adjusted mean difference over days 1-28, 171/min (95% CI; 1 0, 24); P < 0.001) and evening PEFR (adjusted mean difference over day s 1-28, 16 l/min (95% CI; 9, 23); P < 0.001). In addition, diary card symptom scores, beta2-agonist rescue and clinic lung function improved significantly on fluticasone propionate. There were few adverse event s and basal plasma cortisol remained within the normal range. In concl usion fluticasone propionate at 50 mug bd is superior to placebo (curr ent therapy) in the treatment of childhood asthma with no evidence of adverse effects.