A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg; Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg; Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg; Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg; Placebo Metered Dose Inhaler (MDI); Placebo Dry Powder Inhaler (DPI)
Intervention description: MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks; MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks; MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks; MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks; Placebo MDI, 2 puffs BID for 12 weeks; Placebo DPI, 1 puff QD for 12 weeks
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 583.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Children; Persistent

Summary:

      The primary objective of this study is to demonstrate the dose-related efficacy, by
      evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent
      predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of
      three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler
      (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive,
      with persistent asthma. The primary hypothesis of this study is that at least one dose of MF
      MDI BID increases lung function, defined as a significant increase in percent predicted FEV1,
      when compared to Placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of asthma of at least 6 months duration.

          -  Using an Inhaled corticosteroid (ICS), either alone or in combination with a
             long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit
             and must have been on a stable asthma regimen for at least 2 weeks prior to the
             Screening Visit, must not have used oral glucocorticosteroids within 30 days of the
             Screening Visit.

        Exclusion Criteria:

          -  Treated in the emergency room for a severe asthma exacerbation requiring systemic
             glucocorticosteroid treatment, or hospitalization for management of airway obstruction
             within 3 months prior to the Screening Visit.

          -  History of ventilator support for respiratory failure secondary to asthma.

          -  Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks
             prior to Screening and Baseline Visits.

          -  History of clinically significant renal, hepatic, cardiovascular, metabolic,
             neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal,
             cerebrovascular, or other significant medical illness or disorder which, in the
             judgment of the investigator, could interfere with the study or require treatment that
             might interfere with the study. Specific examples include but are not limited to
             insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease
             including hypertension, or conditions that may interfere with respiratory function
             such as, bronchiectasis, and cystic fibrosis. Other conditions that are well
             controlled and stable will not prohibit participation if deemed appropriate per the
             investigator's judgment.

          -  Inability to correctly use an oral MDI or a DPI.

          -  Participation in this study at another investigational site. Participation in a
             different investigational study at any site during the same time frame of this study.

          -  Randomization into this study more than once.

          -  Direct association with either the administration of the this study or the study
             staff.