title: Comparative efficacy and safety of twice daily fluticasone propionate powder versus placebo in the treatment of moderate asthma.
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 L (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.
authors.affiliation: Colorado Allergy and Asthma Clinic, PC, Aurora, USA.
authors.forename: D S
authors.initials: DS
authors.lastname: Pearlman
authors.forename: M J
authors.initials: MJ
authors.lastname: Noonan
authors.forename: D P
authors.initials: DP
authors.lastname: Tashkin
authors.forename: M F
authors.initials: MF
authors.lastname: Goldstein
authors.forename: A G
authors.initials: AG
authors.lastname: Hamedani
authors.forename: D J
authors.initials: DJ
authors.lastname: Kellerman
authors.forename: A
authors.initials: A
authors.lastname: Schaberg
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage; D000730:Androstadienes / Q000008:administration & dosage* / Q000592:standards*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000592:standards*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage; D002648:Child; D002940:Circadian Rhythm; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D010919:Placebos; D011208:Powders; D012129:Respiratory Function Tests
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D010919:Placebos; D011208:Powders; D000068298:Fluticasone; D000420:Albuterol