Fluticasone propionate powder: Oral corticosteroid-sparing effect and improved lung function and quality of life in patients with severe chronic asthma

Background: Many patients with severe asthma are dependent on oral corticos teroids for maintenance control of their disease. Treatments that allow pat ients to be weaned off oral corticosteroids may help to minimize the risk o f side effects associated with their chronic use. Objective: This study evaluated whether inhaled fluticasone propionate powd er could maintain pulmonary function while reducing the dose of oral predni sone in patients with chronic, severe asthma. Methods: Oral prednisone-dependent (5 to 40 mg/day) adolescents and adults with asthma (n = 111; mean FEV1 = 61% of predicted value) were randomized t o placebo or twice daily fluticasone propionate 500 or 1000 mu g administer ed by means of a multidose powder inhaler for 16 weeks in a double-blind, p arallel-group study, Patients underwent controlled prednisone reduction on the basis of predetermined asthma stability criteria. Results: Oral prednisone was eliminated by 75% and 89% of patients in the t wice daily 500 and 1000 mu g fluticasone propionate groups, respectively, v ersus 9% of the placebo group (P < .001). FEV1, morning and evening peak ex piratory flow, asthma symptoms, albuterol use, and nighttime awakenings imp roved with fluticasone propionate treatment, achieving statistical signific ance (P less than or equal to .009) primarily in the 1000 mu g twice daily group. Hypothalamic-pituitary-adrenal axis suppression observed at baseline improved when patients were weaned off oral prednisone to fluticasone prop ionate. Adverse events ascribed to drug treatment were primarily topical ef fects of inhaled corticosteroids or those associated with prednisone withdr awal. Patient quality of life assessed by means of the Asthma Quality of Li fe Questionnaire was clinically and significantly improved after fluticason e propionate treatment (P less than or equal to .003). Conclusion: Fluticasone propionate powder (500 or 1000 mu g twice daily) ef fectively improved lung function, adrenal function, and asthma-specific qua lity of life in patients with severe chronic asthma previously treated with oral prednisone while allowing most patients to be weaned off oral cortico steroid therapy.