Assessment of the effective daily dose for mometasone furoate dry powder inhaler in the treatment of persistent asthma

Abstract

RATIONALE: Mometasone furoate dry powder inhaler (MF-DPI) has been evaluated in several clinical studies for treatment of asthma at an initial dose of 400 mcg/day in mild and moderate persistent asthma. We analyzed the odds that asthma control can be maintained at a maintenance dose of 200 mcg/day. METHODS: Data were pooled from 4 placebo-controlled trials of MF-DPI with regard to asthma severity based on GINA guidelines. Severity was stratified into Steps 2 (mild persistent asthma) and 3 (moderate persistent asthma). The magnitude of response was based on combined increases in FEV1 (≥0.15 L) and AM PEF (≥10 L/min). Odds ratios (OR) and 95% confidence intervals were calculated for responses with MF-DPI 200 mcg/day vs 400 mcg/day, and MF-DPI 200 mcg/day vs placebo. RESULTS: For Step 2 patients (n = 126), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 1.0435 (0.4427, 2.4596); for MF-DPI 200 mcg/day vs placebo the OR was 3.1084 (1.0735, 8.9930). For Step 3 patients (n = 406), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 0.4990 (0.3054, 0.8159), and for MF-DPI 200 mcg/day vs placebo the OR was 2.3421 (1.3119, 4.1817). CONCLUSIONS: Step 2 subjects had approximately equal odds of responding to 200 mcg/day or 400 mcg/day. Although an apparent dose response was seen in Step 3 subjects, a substantial number of patients can be maintained on 200 mcg/day.