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A placebo controlled trial of fluticasone propionate in asthmatic children
Authors:C. A. MacKenzie  E. G. Weinberg  E. Tabachnik  M. Taylor  J. Havnen  K. Crescenzi
Affiliation:(1) Department of Paediatrics, University of Sheffield, Western Bank, S10 2TH Sheffield, UK;(2) Red Cross Children's Hospital, Rondebosch, 7700 Cape Town, South Africa;(3) Pulmonary Paediatrics Department, Kaplan Hospital, Rehovot, Israel;(4) National Children's Hospital, Harcourt Street, Dublin 2, Eire;(5) Paediatric Department, Sentrlsykehuset i Stavanger, 4000 Stavanger, Norway;(6) Glaxo Group Research Ltd, Greenford Road, UB6 OHE Greenford, Middlesex, UK
Abstract: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 mgrg 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, beta2-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 mgrg bd is superior to placebo (current therapy) in the treatment of childhood asthma with no evidence of adverse effects.
Keywords:Asthma  Children  Fluticasone propionate  Clinical trial  HPA-axis function
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