CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 180 enrolled
Drug / intervention
mometasone furoate dry powder inhaler +1 moredrug
Likely dose
mometasone furoate dry powder inhaler 200 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00442117
NCT00442117Phase 3Completed
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A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients

Organon and Co·interventional·Posted Mar 1, 2007·Updated May 20, 2024

In Brief

A Phase 3 clinical trial evaluating mometasone furoate dry powder inhaler and Budesonide DPI for Asthma. Completed, enrolled 180 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2007
Enrollment StartJun 1, 2007
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.3 years ago

Interventions

mometasone furoate dry powder inhalerdrug

MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.

Budesonide DPIdrug

Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.