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* From Saint Francis Hospital & Medical Center (Dr. ZuWallack), Hartford, CT; Dallas Clinical Research (Dr. Adelglass), Dallas, TX; Rocky Mountain Pulmonary and Critical Care Medicine (Dr. Clifford), Wheat Ridge, CO; and Glaxo Wellcome (Ms. Duke, and Drs. Wire, Faris, and Harding), Research Triangle Park, NC.
Correspondence to: Richard ZuWallack, MD, Section of Pulmonary Diseases, Saint Francis Hospital & Medical Center, 114 Woodland St, Hartford, CT 06105
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,
12 years) with a mean FEV1 of 67% predicted normal
were stratified according to baseline therapy of maintenance inhaled
corticosteroids vs ß2-agonists alone.
Measurements and interventions: Fluticasone propionate (250 µg bid or 500 µg 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
FEV1 (p < 0.001), morning (p < 0.001) and evening
peak expiratory flow (PEF; p < 0.001), asthma symptom scores
(p 
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 FEV1, albuterol
use, and withdrawal due to lack of efficacy. During 54 weeks of
open-label treatment, FEV1 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.
Key Words: asthma • Diskus • fluticasone propionate • long-term • once-daily • twice-daily
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