CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 722 enrolled
Drug / intervention
Mometasone furoate/formoterol (MF/F) MDI +1 moredrug
Likely dose
Mometasone furoate/formoterol (MF/F) MDI 10 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/NCT00424008
NCT00424008Phase 3Completed
CompareCT.gov

A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids

Organon and Co·interventional·Posted Jan 18, 2007·Updated May 20, 2024

In Brief

A Phase 3 clinical trial evaluating Mometasone furoate/formoterol (MF/F) MDI and Fluticasone propionate/salmeterol (F/SC) DPI for Asthma. Completed, enrolled 722 participants.

Detailed Summary

This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2007
Enrollment StartApr 1, 2007
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.5 years ago

Interventions

Mometasone furoate/formoterol (MF/F) MDIdrug

MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.

Fluticasone propionate/salmeterol (F/SC) DPIdrug

Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.