Fluticasone propionate improves quality of life in patients with asthma requiring oral corticosteroids

Background: Fluticasone propionate is a potent inhaled corticosteroid that is effective in improving pulmonary function and symptoms in patients with asthma. Objective: To evaluate the effects of fluticasone propionate on quality of life in patients with severe asthma requiring oral corticosteroids. Methods: A total of 96 patients with severe asthma participated in a randomized, double-blind, placebo-controlled, parallel-group, oral steroid-sparing study. Patients received fluticasone propionate aerosol, 750 or 1000 mu g bid, or Placebo for 16 weeks; 91 of these patients continued in a 1-year open-label study, in which everyone initially received fluticasone propionate, 1000 mu g bid. At regular intervals, patients completed the Medical Outcomes Study Short Form-36 (SF-36), a general health status questionnaire measuring eight dimensions of quality of life, plus one question on change in health from the previous year. Results: Compared with the US population, patients scored significantly lower at baseline for five of eight SF-36 dimensions (P < .01). After 16 weeks, patients receiving fluticasone propionate, 1000 mu g, improved significantly (P less than or equal to .02) in physical functioning, role-physical, general health, and change in health, compared with the placebo group. After 1 year of open-label treatment with fluticasone propionate, these improvements were maintained. SF-36 scores in the placebo group during the double-blind period either worsened or remained unchanged; however, when these patients were switched to fluticasone propionate during the open-label period, their SF36 scores also improved. Forced expiratory volume in 1 second (FEV(1)) at the end of the double-blind period was positively correlated with mean quality of life scores on physical functioning, role-physical, vitality, social functioning, and change-in-health status. Conclusion: Health-related quality of life improved in patients with severe asthma following 16 weeks of treatment with fluticasone propionate, 1000 mu g bid. These improvements were maintained during subsequent fluticasone propionate treatment over a 1-year period.