Efficacy and safety of fluticasone propionate 250 μg administered once daily in patients with persistent asthma treated with or without inhaled corticosteroids

Background: Studies have shown fluticasone propionate (FP) 100, 200, and 500 mug administered once daily to be effective in the treatment of asthma. The efficacy of a once daily regimen of FP 250 mug has not been evaluated previously. Objective: We sought to evaluate the efficacy and safety of inhaled FP 250 mug administered once daily in patients currently receiving inhaled short-acting beta-agonists (SABA) alone or inhaled corticosteroids (ICS). Methods: In two separate studies, 408 patients in the SABA study and 401 patients in the ICS study were randomly assigned to receive FP 250 mug or placebo for 12 weeks through the Diskus device (GlaxoSmithKline, Research Triangle Park, NC) each morning. Results: At the study endpoint, SABA patients treated with FP and placebo had mean increases in forced expiratory volume in 1 second from baseline of 0.23+/-0.03 L and 0.10+/-0.03 L, respectively (P<0.001). ICS patients treated with FP had a mean increase of 0.08 +/- 0.02 L compared with a decrease in forced expiratory volume in 1 second of -0.08 +/- 0.03 L with placebo (P<0.001). Changes of similar magnitude in morning peak expiratory flow rates were seen with FP in both the SABA and ICS studies. Fewer FP-treated ICS study patients were withdrawn from the study as a result of predetermined asthma stability criteria and, therefore, those patients had a greater probability of remaining in the study than placebo-treated patients (P<0.001). Conclusions: FP 250 mu g, once daily, produced greater improvements in pulmonary function and asthma symptom control than placebo. This new treatment regimen provides clinicians with an additional therapeutic option for patients with asthma previously treated with either beta(2)-agonists alone or ICS.