Who is sponsoring NCT00442117?

NCT00442117 is sponsored by Organon and Co.

What drugs are being tested in NCT00442117?

Interventions: mometasone furoate dry powder inhaler, Budesonide DPI.

What is the status of NCT00442117?

NCT00442117 is currently COMPLETED.

Last reviewed 2024-05-08 · How we verify

A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients

NCT00442117 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Organon and Co
Phase	Phase 3
Status	COMPLETED
Enrolment	180
Start date	2007-06
Completion	2009-07

Conditions

Asthma

Interventions

mometasone furoate dry powder inhaler
Budesonide DPI

Primary outcomes

Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12. — Baseline and Week 12
FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.