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Clinical Investigations: ASTHMA |

Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma*

Richard ZuWallack, MD; Jeffery Adelglass, MD; Dennis P. Clifford, MD, FCCP; Susan P. Duke, MS; Patrick D. Wire, PharmD; Melissa Faris, PharmD; Stuart M. Harding, MD
Author and Funding Information

*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



Chest. 2000;118(2):303-312. doi:10.1378/chest.118.2.303
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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 β2-agonists alone.

Measurements and interventions: Fluticasone propionate (250μ g 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.

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