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)
Condition: Asthma
MeSH terms: Asthma
Intervention: MF MDI 100 mcg BID (Open Label); MF/F MDI 100/10 mcg BID; MF MDI 100 mcg BID; Albuterol/Salbutamol PRN; Prednisone/Prednisolone
Intervention description: Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.; 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.; 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.; Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.; Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.
Intervention MeSH terms: Mometasone Furoate; Prednisone; Prednisolone; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: 1:1 randomization to double-blinded MF/F MDI 100/10 mcg BID and MF MDI 100 mcg BID
Enrollment: 181.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No

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.
    

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