CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 272 enrolled
Drug / intervention
SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )drug
Likely dose
SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) 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/NCT00604500
NCT00604500Phase 3Completed
CompareCT.gov

An Open-Label, Multi-Center, Patient Handling Study of Mometasone Furoate/Formoterol Fumarate MDI With an Integrated Dose Counter in Adolescent and Adult Subjects and Adult With Asthma or COPD

Organon and Co·interventional·Posted Jan 30, 2008·Updated May 20, 2024

In Brief

A Phase 3 clinical trial evaluating SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) for Asthma and COPD. Completed, enrolled 272 participants.

Detailed Summary

This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, COPD
Countries--
CollaboratorsNovartis

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2008
Enrollment StartMar 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.4 years ago

Interventions

SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )drug

MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.