PURPOSE: To evaluate the effects of mometasone furoate dry powder inhaler (MF-DPI) on lung function in patients stratified by baseline asthma severity.
METHODS: This was a randomized, double-blind, placebo-controlled study conducted at 18 centers in the United States. Patients (≥12 y) who had asthma for at least 6 months and were previously using only short-acting inhaled beta-agonists (SABAs) were randomized to receive MF-DPI 200 μg once daily in the evening or placebo for 12 weeks. The primary outcome was change from baseline at endpoint (last postbaseline value) in forced expiratory volume in 1 second (FEVî). Patients were further stratified based on asthma severity (FEVî <80% [more severe] or ≥80% [milder] of the predicted value) at baseline. Two-way analysis of variance, with treatment and center as factors, was used for data analysis.
RESULTS: 195 patients (MF-DPI, n=100; placebo, n=95) were randomized and treated; 134 and 61 patients were classified as having more severe (FEVî <80%) and milder (FEVî ≥80%) asthma, respectively. At endpoint, the mean percent change from baseline was 16.8% for MF-DPI and 6.0% for placebo (P<0.01). Patients with more severe asthma showed significant improvement in FEVî with MF-DPI versus placebo (mean percent change, 20.7% vs 5.1%; P<0.05). In these patients, improvement was seen as early as week 1 and was maintained throughout the remainder of the study. Milder asthma patients showed smaller, numerical improvements (mean percent change, 7.8% both), which may be attributable to a ceiling effect of FEVî ≥80%. Headache (both, 28%), rhinitis (18% vs 14%), upper respiratory infection (14% vs 13%), and pharyngitis (13% vs 6%) were the most common adverse events for MF-DPI and placebo, respectively.
CONCLUSION: Once-daily evening administration of MF-DPI 200 μg provided significant improvement in lung function.
CLINICAL IMPLICATIONS: MF-DPI 200 μg once daily in the evening improves lung function in patients previously using only SABAs, with greater improvements in patients with worse pretreatment lung function.
DISCLOSURE: Joe Ramsdell, None.