A placebo controlled trial of fluticasone propionate in asthmatic children

Fluticasone propionate is a synthetic steroid for use by the inhaled route. It's high topical potency and low systemic bioavailability make it suitable for use in asthmatic children. A total of 258 children were randomised in a double-blind study to receive fluticasone propionate (50 micrograms...

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Bibliographic Details
Published in:European journal of pediatrics 1993-10, Vol.152 (10), p.856-860
Main Authors: MACKENZIE, C. A, WEINBERG, E. G, TABACHNIK, E, TAYLOR, M, HAVNEN, J, CRESCENZI, K
Format: Article
Language:English
Subjects:
Administration, Inhalation
Administration, Topical
Adolescent
Androstadienes - administration & dosage
Androstadienes - adverse effects
Anti-Inflammatory Agents - administration & dosage
Anti-Inflammatory Agents - adverse effects
Asthma - drug therapy
Asthma - physiopathology
Biological and medical sciences
Child
Double-Blind Method
Female
Fluticasone
Forced Expiratory Volume - drug effects
Glucocorticoids
Humans
Male
Medical sciences
Peak Expiratory Flow Rate - drug effects
Pharmacology. Drug treatments
Respiratory system
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Summary:Fluticasone propionate is a synthetic steroid for use by the inhaled route. It's high topical potency and low systemic bioavailability make it suitable for use in asthmatic children. A total of 258 children were randomised in a double-blind study to receive fluticasone propionate (50 micrograms bd) as the dry powder formulation inhaled via a Diskhaler inhaler, or matched placebo (with current therapy) for 4 weeks throughout which time diary cards were completed. During clinic visits lung function and adrenal function were measured. Fluticasone propionate produced a significantly greater increase in morning peak expiratory flow rate (PEFR) (adjusted mean difference over days 1-28, 17 l/min (95% CI; 10, 24); P < 0.001) and evening PEFR (adjusted mean difference over days 1-28, 16 l/min (95% CI; 9, 23); P < 0.001). In addition, diary card symptom scores, beta 2-agonist rescue and clinic lung function improved significantly on fluticasone propionate. There were few adverse events and basal plasma cortisol remained within the normal range. In conclusion fluticasone propionate at 50 micrograms bd is superior to placebo (current therapy) in the treatment of childhood asthma with no evidence of adverse effects.
ISSN:0340-6199
1432-1076
DOI:10.1007/BF02073387