drugset / Trial / NCT00442117

A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)

NCT00442117

Phase 3 Completed 180 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.

Timeline

Start
2007-06
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 200 ug Inhaled
Subject Mometasone furoate Other / unclassified 200 ug Inhaled

Indications