IngentaConnect Comparative Efficacy and Safety of Twice Daily Fluticasone Propio...

Authors: Pearlman, David S.; Noonan, Michael J.; Tashkin, Donald P.; Goldstein, Marc F.; Hamedani, Abbas G.; Kellerman, Donald J.; Schaberg, Amy

Source: Annals of Allergy, Asthma and Immunology, Volume 78, Number 4, April 1997 , pp. 356-362(7)

Publisher: American College of Allergy, Asthma, & Immunology

Abstract:

Background: Fluticasone propionate, an inhaled corticosteroid with negligible systemic bioavailability via the oral route, is efficacious in the treatment of asthma when administered via metered-dose inhaler.

Objective: To evaluate the efficacy and safety of inhaled fluticasone propionate powder in patients with moderate asthma previously treated with an inhaled corticosteroid.

Methods: This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of 342 adolescent and adult patients with moderate asthma [forced expiratory volume in 1 second (FEV₁) between 50% and 80% of predicted] treated previously by beclomethasone dipropionate or triamcinolone acetonide. Patients received fluticasone propionate powder 50 micrograms, 100 micrograms, 250 micrograms, or placebo via a breath-actuated inhalation device, the Diskhaler, twice daily for 12 weeks.

Results: Patients in the fluticasone propionate groups experienced a mean increase from baseline to endpoint in FEV₁ ranging from 0.43 L to 0.47 L. Patients in the placebo group experienced a mean decrease from baseline of 0.22 (P < .001). The probability of patients remaining in the study over time without developing signs of exacerbating asthma was significantly greater in the fluticasone propionate groups than in the placebo group (P = .001). Asthma symptom scores, supplemental rescue albuterol use, and number of nighttime awakenings due to asthma requiring treatment also improved significantly with all fluticasone propionate treatment regimens compared with placebo (P < .001). There were no statistically significant differences at endpoint among the three fluticasone propionate groups. No serious drug-related adverse events occurred.

Conclusions: Fluticasone propionate powder (50, 100, and 250 micrograms) was well-tolerated and significantly improved lung function in patients with moderate asthma.

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Comparative Efficacy and Safety of Twice Daily Fluticasone Propionate Powder Versus Placebo in the Treatment of Moderate Asthma