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

Abstract

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.

Research design and methods:

This was an 8-week open-label study conducted in Japanese patients ≥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 µg/day, taken as 100 µg 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.

Conclusion:

MF-DPI 100 µg BID is an effective treatment for Japanese patients with intermittent or mild persistent asthma.

Key words::

• Asthma control
• Asthma treatment
• Dry powder inhaler
• Inhaled corticosteroids
• Mometasone furoate

Transparency

Declaration of funding

The research was sponsored by Schering-Plough K. K., Osaka, Japan. The participating investigators were Mitsuhide Ohmichi, MD; Shin Tsutahara, MD; Hideki Ikeda, MD; Hitomi Tatsuta, MD; Takuji Ujita, MD; Tsuneo Yamaga, MD; and Masaaki Uenishi, MD.

Declaration of financial/other relationships

Y.T. and T.M have disclosed that they have received sponsorship from Schering Plough.

All peer reviewers receive honoraria from CMRO for their review work. The peer reviewers have disclosed that they have no relevant financial relationships.

Acknowledgments

Editorial assistance was provided by Ken Kauffman, BSc. This assistance was funded by Schering-Plough, Kenilworth, NJ, USA.

Notes

* Asmanex is a registered trademark of Schering Corporation, Kenilworth, NJ, USA.