STUDY OBJECTIVE: In September 2000, the US Food and Drug Administration (FDA) approved the use of Flovent Diskus (FD) [ @entity5023 ; GlaxoSmithKline; Research Triangle Park, NC], which is an orally inhaled, dry-powder corticosteroid, for the maintenance treatment of @entity565 at dosages of 50 to 1,000 microg administered twice-daily. Once-daily dosage regimens did not receive approval. This article will detail six clinical trials, five of which incorporated comparative once-daily and twice-daily treatment arms of the same nominal dose of FD. DESIGN: Six 12-week, randomized, double-blind, placebo-controlled studies in @entity1 with mild-to-moderate @entity565 , including two pediatric @entity565 trials ( @entity1 age, 4 to 11 years) of total daily doses of @entity5023 (FP) of 100 or 200 microg, and four adult and adolescent studies of total daily doses of FP of 100, 200, or 500 microg. RESULTS: Twice-daily dosing was numerically superior to once-daily dosing at the same nominal dose in all comparative studies for the primary end point, change in predose FEV(1). In five trials, the results of the once-daily dosage of FP were statistically indistinguishable from those with placebo. One trial demonstrated the superiority of FP, 500 microg once-daily, over placebo; however, the effect size was half that observed with twice-daily dosing. Once-daily FP dosing showed no advantage in safety or in @entity1 adherence to medication. CONCLUSIONS: In the FDA review of once-daily dosing of the FD regimen, 100 or 200 microg once-daily dosing was not shown to be significantly better than placebo. FP 500 microg once-daily was found to be superior to placebo, but at about one half the effect size as the same nominal dose given bid. No advantage in @entity1 safety or adherence was demonstrated for once-daily administration over twice-daily administration, and once-daily administration is not currently recommended.

Inhaled @entity5023 by diskus in the treatment of XXXX : a comparison of the efficacy of the same nominal dose given either once or twice a day.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity565 :: ('MESH:D001249', 'Disease') :: ['asthma'] @entity5023 :: ('MESH:C065382', 'Chemical') :: ['fluticasone propionate']
@entity565 :: (MESH:D001249,Disease) :: ['asthma']
