Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)

Phase 3 Completed 181 enrolled Organon and Co

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2016-05-11
Primary completion: 2017-12-04
Completion: 2017-12-04

Outcome

Met primary endpoint

registry MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID; p <0.001; LSM Difference 5.21 (95% CI 3.21 to 7.20) NCT02741271 ↗

Publications

Results Weinstein CLJ, Gates D, Zhang X, Varnell T, Mok W, Vermeulen JH, Amar NJ, Jain N. A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma. Pediatr Pulmonol. 2020 Apr;55(4):882-889. doi: 10.1002/ppul.24667. Epub 2020 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Formoterol	Other / unclassified	10 ug	Inhaled
Subject	Mometasone furoate	Other / unclassified	100 ug	Inhaled
Background	Prednisolone	Other / unclassified	—	—
Background	Prednisone	Other / unclassified	—	—
Background	Salbutamol	Unknown	—	—