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


METHODS
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.


RESULTS
Twenty patients received MF-DPI, and 19 patients (nine with intermittent asthma and 10 with mild persistent asthma) were included in the full analysis set (FAS). The mean AM PEF and PM PEF values increased by 9.1% (P < 0.0001) and 7.3% (P < 0.0001), respectively, in the FAS. Improvements in AM and PM PEF occurred as early as week 1 and were sustained throughout treatment. Improvements at week 8 in forced expiratory volume in 1 second and forced vital capacity were 11.0% and 8.2%, respectively. Notable decreases occurred for subjective symptom scores. The reported AEs were mild to moderate in severity. Study limitations include the small sample size and open-label treatment. This study was planned as the first study of MF-DPI in Japanese mild asthma patients without receiving other inhaled steroids. In addition, the cost:benefit ratio of MF-DPI in patients with intermittent asthma was not addressed.


CONCLUSIONS
MF-DPI 100 microg BID is an effective treatment for Japanese patients with intermittent or mild persistent asthma.
Tohda
Yuji
Y
Department of Respiratory Medicine and Allergology, Kinki University School of Medicine, Osaka-Sayama City, Japan. tohda@med.kindai.ac.jp
Miyamoto
Terumasa
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D010349:Patient Compliance; D010366:Peak Expiratory Flow Rate; D011244:Pregnadienediols / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate