Comparative efficacy and safety of twice daily fluticasone propionate powder versus placebo in the treatment of moderate asthma

Ann Allergy Asthma Immunol. 1997 Apr;78(4):356-62. doi: 10.1016/S1081-1206(10)63196-1.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Albuterol / administration & dosage
  • Androstadienes / administration & dosage*
  • Androstadienes / standards*
  • Anti-Asthmatic Agents / administration & dosage*
  • Anti-Asthmatic Agents / standards*
  • Asthma / drug therapy*
  • Bronchodilator Agents / administration & dosage
  • Child
  • Circadian Rhythm
  • Double-Blind Method
  • Female
  • Fluticasone
  • Humans
  • Male
  • Placebos
  • Powders
  • Respiratory Function Tests


  • Androstadienes
  • Anti-Asthmatic Agents
  • Bronchodilator Agents
  • Placebos
  • Powders
  • Fluticasone
  • Albuterol