The Journal of Allergy and Clinical Immunology
Volume 94, Issue 4 , Pages 676-683, October 1994

Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma☆

North Dartmouth, Mass., U.S.A.

Received 14 April 1993; received in revised form 7 January 1994; accepted 30 March 1994.

Article Outline

Abstract 

Background: Recent emphasis on the control of airway inflammation in asthma highlights the need for safe and effective antiinflammatory agents. Fluticasone propionate is one of the most potent antiinflammatory corticosteroids developed to date.

Objective: This study assessed the safety and efficacy of fluticasone propionate aerosol in the treatment of mild to moderate asthma.

Methods: Fluticasone propionate aerosol (25, 100, or 500 μg twice daily) or placebo was given for as long as 8 weeks to adults with mild to moderate asthma in a randomized, double-blind, parallel-group study. Patients were removed from the study if they showed predefined signs of worsening asthma.

Results: Sixty-three percent of placebo-treated patients and 23%, 13%, and 4% of patients treated with fluticasone propionate 25, 100, and 500 μg twice daily, respectively, were removed from the study. Mean forced expiratory volume in 1 second, forced vital capacity, and forced expiratory flow at midexpiratory phase at weekly visits throughout the study demonstrated that fluticasone propionate was more efficacious than placebo in maintaining asthma control. Measurements of peak expiratory flow and symptom scores significantly improved and nighttime awakenings and albuterol use to treat symptoms significantly declined in fluticasone propionate-treated groups relative to the placebo-treated group. Differences among fluticasone propionate groups for these variables were not statistically significant. Incidence and severity of adverse events were similar across groups. Fluticasone propionate did not affect morning or stimulated plasma cortisol concentrations, although slight, transient reductions in urinary free cortisol and urinary 17-hydroxy steroids occurred in the group receiving 500 μg fluticasone propionate twice daily.

Conclusion: These data indicate that fluticasone propionate provides safe and effective treatment for mild to moderate asthma.

Keywords:  Asthma, fluticasone propionate, inhaled corticosteroid

Abbreviations:  FEF25%–75%, Forced expiratory flow at midexpiratory phase, FEV1, Forced expiratory volume in 1 second, FVC, Forced vital capacity, PFT, Pulmonary function tests

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☆ This study was funded in part by Glaxo Research Institute.

PII: 0091-6749(94)90174-0

The Journal of Allergy and Clinical Immunology
Volume 94, Issue 4 , Pages 676-683, October 1994

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