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)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: MF/F MDI 100/10 mcg BID; Drug: Albuterol/Salbutamol PRN; Drug: Prednisone/Prednisolone; Drug: MF MDI 100 mcg BID (Open Label); Drug: MF MDI 100 mcg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02741271

2009-010110-30 (EudraCT Number)

MK-0887A-087 (Other Identifier)

0887A-087

Details and patient eligibility

About

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.

Enrollment: 181 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines
• Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks
• Is able to demonstrate an FEV1 >60% and ≤90% predicted
• Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol.
• Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.
• Is willing (with consent of their parent(s)/guardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy.
• Has laboratory tests that are clinically acceptable to the investigator.

Exclusion criteria

• Requires >8 inhalations per day of albuterol (100 mcg per actuation), and/or >2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days
• Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.
• Is considered by the investigator to have unstable asthma at the end of the run-in period
• Has had > 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1
• Has had a history of life-threatening asthma
• Has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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181 participants in 2 patient groups

MF/F MDI 100/10 mcg BID

Experimental group

Description:

Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.

Treatment:

Drug: MF MDI 100 mcg BID (Open Label)

Drug: Prednisone/Prednisolone

Drug: Albuterol/Salbutamol PRN

Drug: MF/F MDI 100/10 mcg BID

MF MDI 100 mcg BID

Active Comparator group

Description:

Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.

Treatment:

Drug: MF MDI 100 mcg BID

Drug: MF MDI 100 mcg BID (Open Label)

Drug: Prednisone/Prednisolone

Drug: Albuterol/Salbutamol PRN