FLUTICASONE PROPIONATE AEROSOL - EFFICACY IN PATIENTS WITH MILD-TO-MODERATE ASTHMA

Background. This double-blind, randomized, parallel group, placebo-con trolled study investigated the efficacy and tolerability of fluticason e propionate aerosol (25, 50, or 100 mu g bid for 12 weeks) administer ed as primary maintenance therapy to patients whose mild to moderate a sthma was inadequately controlled by as-needed use of an inhaled beta- agonist. Results. At all clinic visits, fluticasone propionate compare d with placebo was associated with significant (P<.05) improvement in pulmonary function indexed by forced expiratory volume in 1 second (FE V(1)) as well as fewer night awakenings and less use of rescue albuter ol. Values for patient-measured morning peak expiratory flow rates (PE FR) were significantly (P<.05) higher and the use of rescue albuterol was significantly (P<.05) lower beginning 3 to 5 days after initiation of therapy in the groups treated with fluticasone propionate, compare d with the placebo group. Maximal improvement in FEV, was achieved dur ing the second week of treatment and maintained throughout the course of therapy. Differences among the three fluticasone propionate dosing groups for these efficacy measures were not statistically significant. The incidence of adverse similar across groups. Conclusions. These da ta indicate that fluticasone propionate aerosol is an effective and we ll-tolerated treatment for asthma and significantly improves pulmonary function within days of initiation of treatment in patients whose ast hma is inadequately controlled with as-needed beta-agonists.