drugset / Trial / NCT00521599

A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828)

NCT00521599

Phase 4 Completed 672 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

Summary

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).

Timeline

Start
2007-05
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Mometasone furoate Other / unclassified 100 ug Inhaled
Subject Mometasone furoate Other / unclassified 200 ug Inhaled

Indications