Ca. Mackenzie et al., A PLACEBO-CONTROLLED TRIAL OF FLUTICASONE PROPIONATE IN ASTHMATIC-CHILDREN, European journal of pediatrics, 152(10), 1993, pp. 856-860
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.