CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 181 enrolled
Drug / intervention
MF MDI 100 mcg BID (Open Label) +4 moredrug
Likely dose
MF MDI 100 mcg BID (Open Label)from 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/NCT02741271
NCT02741271Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children With Persistent Asthma

Organon and Co·interventional·Posted Apr 18, 2016·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating MF MDI 100 mcg BID (Open Label), MF/F MDI 100/10 mcg BID, and 3 other interventions for Asthma. Completed, enrolled 181 participants.

Detailed Summary

This study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (MF/F) 100/10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma.

Study Details

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

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 18, 2016
Enrollment StartMay 11, 2016
Primary CompletionDec 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.2 years ago

Interventions

MF MDI 100 mcg BID (Open Label)drug

Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.

MF/F MDI 100/10 mcg BIDdrug

After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF/F MDI 100/10 mcg BID.

MF MDI 100 mcg BIDdrug

After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID.

Albuterol/Salbutamol PRNdrug

Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.

Prednisone/Prednisolonedrug

Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.