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)

PHASE3CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

May 11, 2016

Primary Completion Date

December 4, 2017

Study Completion Date

December 4, 2017

Conditions
Asthma
Interventions
DRUG

MF MDI 100 mcg BID (Open Label)

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

DRUG

MF/F MDI 100/10 mcg BID

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.

DRUG

MF MDI 100 mcg BID

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.

DRUG

Albuterol/Salbutamol PRN

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

DRUG

Prednisone/Prednisolone

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

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT02741271 - 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) | Biotech Hunter | Biotech Hunter