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)

NCT ID: NCT02741271

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-11
• Study Completion Date: 2017-12-04

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MF/F MDI 100/10 mcg BID

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

Group Type: EXPERIMENTAL

MF MDI 100 mcg BID (Open Label)

Intervention Type: 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 BID

Intervention Type: DRUG

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.

Albuterol/Salbutamol PRN

Intervention Type: DRUG

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

Prednisone/Prednisolone

Intervention Type: DRUG

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

MF MDI 100 mcg BID

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

Group Type: ACTIVE_COMPARATOR

MF MDI 100 mcg BID (Open Label)

Intervention Type: DRUG

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

MF MDI 100 mcg BID

Intervention Type: DRUG

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 PRN

Intervention Type: DRUG

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

Prednisone/Prednisolone

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Prednisone/Prednisolone

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

Intervention Type: DRUG

Other Intervention Names

ASMANEX HFA®; SCH 032088 (MK-0887); DULERA®/ZENHALE®; SCH 418131 (MK-0887A); ASMANEX HFA®; SCH 032088 (MK-0887)

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 32022483 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-0887A-087

Identifier Type: OTHER

Identifier Source: secondary_id

2009-010110-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0887A-087

Identifier Type: -

Identifier Source: org_study_id