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Inhaled Fluticasone Propionate by Diskus in the Treatment of Asthma^*

A Comparison of the Efficacy of the Same Nominal Dose Given Either Once or Twice a Day

^* From the Division of Pulmonary and Allergy Drug Products (Drs. Purucker and Rosebraugh), the Division of Biometrics (Dr. Zhou), and the Office of Drug Evaluation II (Dr. Meyer), Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD.

Correspondence to: Curtis J. Rosebraugh, MD, MPH, Division of Over The Counter Drug Products 5600 Fisher Ln, HFD-560 Rockville, MD 20857; email: RosebraughC{at}cder.fda.gov

Study objective: In September 2000, the US Food and Drug Administration (FDA) approved the use of Flovent Diskus (FD) [fluticasone propionate; GlaxoSmithKline; Research Triangle Park, NC], which is an orally inhaled, dry-powder corticosteroid, for the maintenance treatment of asthma at dosages of 50 to 1,000 µg 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 patients with mild-to-moderate asthma, including two pediatric asthma trials (patient age, 4 to 11 years) of total daily doses of fluticasone propionate (FP) of 100 or 200 µg, and four adult and adolescent studies of total daily doses of FP of 100, 200, or 500 µg.

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 FEV₁. 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 µg 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 patient adherence to medication.

Conclusions: In the FDA review of once-daily dosing of the FD regimen, 100 or 200 µg once-daily dosing was not shown to be significantly better than placebo. FP 500 µg 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 patient safety or adherence was demonstrated for once-daily administration over twice-daily administration, and once-daily administration is not currently recommended.

Key Words: asthma • Diskus • dose regimen • Flovent • fluticasone propionate • multidose powder inhaler • pediatric study

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