Long-term efficacy and safety of fluticasone propionate powder administered once or twice daily via inhaler to patients with moderate asthma

Chest. 2000 Aug;118(2):303-12. doi: 10.1378/chest.118.2.303.


Objective: To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma.

Design: Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks).

Setting: Multicenter study in an outpatient setting.

Participants: Patients (n = 253; age, > or = 12 years) with a mean FEV(1) of 67% predicted normal were stratified according to baseline therapy of maintenance inhaled corticosteroids vs beta(2)-agonists alone.

Measurements and interventions: Fluticasone propionate (250 microg bid or 500 microg qd) or placebo (bid) was administered via the Diskus multidose powder inhaler (Glaxo Wellcome; Research Triangle Park, NC) for 12 weeks. During open-label treatment, patients were re-randomized to once-daily or twice-daily fluticasone propionate.

Results: Compared to placebo, fluticasone propionate administered qd or bid significantly improved FEV(1) (p < 0.001), morning (p < 0.001) and evening peak expiratory flow (PEF; p < 0.001), asthma symptom scores (p < or = 0.001), and albuterol use (p </= 0.001), and decreased nighttime awakenings. By the end of 12 weeks, withdrawal due to lack of efficacy was significantly higher in the placebo group than in the once-daily (p = 0.001) or twice-daily (p < 0.001) groups. When comparing the two active dosing regimens, significant differences in favor of twice-daily dosing were noted in FEV(1), albuterol use, and withdrawal due to lack of efficacy. During 54 weeks of open-label treatment, FEV(1) and PEF continued to improve with both regimens, and improvements seen in the first 12 weeks were maintained in patients who switched from twice-daily to once-daily dosing. Fluticasone propionate treatment over a 54-week period was well tolerated, with few drug-related adverse events, which were primarily topical effects of inhaled corticosteroids.

Conclusions: Fluticasone propionate powder improved lung function when administered either qd or bid over a 1-year period to patients with moderate asthma, with twice-daily dosing demonstrating significantly greater improvement in some efficacy parameters than once-daily dosing over the first 12 weeks of treatment. Fluticasone propionate treatment was not associated with significant systemic effects.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adrenergic beta-Agonists / administration & dosage
  • Adult
  • Aged
  • Albuterol / administration & dosage
  • Androstadienes / administration & dosage*
  • Anti-Asthmatic Agents / administration & dosage*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Child
  • Circadian Rhythm
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Fluticasone
  • Follow-Up Studies
  • Forced Expiratory Volume / drug effects
  • Humans
  • Male
  • Middle Aged
  • Nebulizers and Vaporizers
  • Powders
  • Safety
  • Severity of Illness Index


  • Adrenergic beta-Agonists
  • Androstadienes
  • Anti-Asthmatic Agents
  • Powders
  • Fluticasone
  • Albuterol