@article {Pearlman:April 1997:1081-1206:356, author = "Pearlman, David S.", author = "Noonan, Michael J.", author = "Tashkin, Donald P.", author = "Goldstein, Marc F.", author = "Hamedani, Abbas G.", author = "Kellerman, Donald J.", author = "Schaberg, Amy", title = "Comparative Efficacy and Safety of Twice Daily Fluticasone Propionate Powder Versus Placebo in the Treatment of Moderate Asthma", journal = "Annals of Allergy, Asthma and Immunology", volume = "78", year = "April 1997", 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.", pages = "356-362(7)", url = "http://www.ingentaconnect.com/content/acaai/aaai/1997/00000078/00000004/art00005" }