EFFECTIVENESS OF FLUTICASONE PROPIONATE IN PATIENTS WITH MODERATE ASTHMA - A DOSE-RANGING STUDY

This study was undertaken to evaluate the efficacy and safety of fluti casone propionate, an inhaled corticosteroid, in adolescents and adult s with moderate asthma who were previously taking inhaled corticostero ids. After a 2-week, open-label screening period, a double-masked, ran domized, parallel-group, dose-ranging study was conducted over 12 week s in 21 outpatient centers throughout the United States. Patients (N = 304) greater than or equal to 12 years of age with moderate asthma pr eviously treated with inhaled corticosteroids and beta-sympathomimetic bronchodilators were enrolled. Patients were assigned to receive plac ebo or fluticasone propionate 100, 250, or 500 mu g twice daily via a metered-dose inhaler without a spacer device. These doses refer to the amount of fluticasone propionate released from the valve of the meter ed-dose inhaler; the corresponding doses released from the activator o f the metered-dose inhaler are 88 mu g, 220 mu g, and 440 mu g, respec tively. Between baseline and end point, mean values of forced expirato ry volume in 1 second decreased 0.31 Lin the placebo group and improve d 0.39 L, 0.30 L, and 0.43 L in patients receiving 100-mu g, 250-mu g, and 500-mu g fluticasone propionate, respectively. The differences be tween placebo and all treatment groups were statistically significant. More patients were withdrawn from placebo (72%) than from fluticasone propionate (13% to 16%) because of failure to meet predetermined asth ma stability criteria. Differences in baseline-to-end point changes in morning peak expiratory flow rate, physician overall assessments and patient-rated assessment of symptoms, and albuterol use for symptom co ntrol also significantly favored each fluticasone propionate group ove r placebo. There were;essentially no differences in efficacy among the three fluticasone propionate groups. Treatment-related adverse events occurred in 8% of placebo-treated patients and 13% to 15% of fluticas one propionate-treated patients; these events were mainly localized to the oropharynx/larynx. A 12-week course of fluticasone propionate (10 0, 250, and 500 mu g twice daily) was well tolerated and more effectiv e than placebo based on maintenance of asthma stability, pulmonary fun ction tests, physician and patient assessments, and rescue bronchodila tor use. No dose-related effects were observed with the dosages of flu ticasone propionate used in this study.