Efficacy, safety, and tolerability of mometasone furoate in adult Japanese patients with mild asthma: open-label clinical trial findings

Current Medical Research and Opinion
Yuji Tohda, Terumasa Miyamoto

Abstract

To evaluate the clinical efficacy and safety of mometasone furoate administered via a dry powder inhaler (MF-DPI) in Japanese patients with intermittent or mild persistent asthma who were not previously receiving inhaled corticosteroids. This was an 8-week open-label study conducted in Japanese patients > or =16 years of age with intermittent or mild persistent asthma. All patients provided informed written consent before baseline and were treated with MF-DPI 200 microg/day, taken as 100 microg twice daily (BID). Inhaled steroids other than the study drug are not used, the drugs used previously are continued, dose of concomitant drug may be reduced if symptoms are improved and no new drugs were allowed during the trial. The primary efficacy variable was the change from baseline in morning peak expiratory flow (AM PEF). Secondary efficacy variables were evening (PM) PEF, spirometric measurements of lung function, and subjective symptoms. Descriptive statistics and standard errors were calculated for each efficacy evaluation. The safety of MF-DPI treatment was evaluated by measuring adverse events (AEs) and laboratory tests. Twenty patients received MF-DPI, and 19 patients (nine with intermittent asthma and 10 with mild persisten...Continue Reading

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