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A Study of the Therapeutic Equivalency of MF DPI 100 mcg and 200 mcg Inhalers in Corticosteroid-Dependent Subjects With Moderate Asthma
This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs when providing the same total daily dose (400 mcg/day).
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 672 |
| Start date | 2007-05 |
| Completion | 2009-03 |
Conditions
- Asthma
Interventions
- Mometasone furoate dry powder inhaler
- Placebo
Primary outcomes
- Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8. — Baseline and Week 8 End
Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.