A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
Condition: Asthma
MeSH terms: Asthma
Intervention: Formoterol Fumarate DPI; Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer; Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer; Placebo MDI with spacer; Placebo MDI without spacer; Mometasone Furoate DPI
Intervention description: Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose; Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of MF DPI 100 mcg administered as a single dose once daily at night. Used as maintenance therapy during screening and in between single doses of study drug.
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 92.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: asthma; children; persistent

Summary:

      A study to compare the bronchodilatory effect of a single dose of Mometasone
      Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and
      without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus
      Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler
      (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant
      was to receive a single dose of each of 4 treatments in each period. Each treatment period
      was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10
      microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a
      significant increase in forced expiratory volume in one second (FEV1) area under the curve
      from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a diagnosis of asthma of at least 6 months duration

          -  Must have taken an Inhaled Corticosteroid ([ICS]; alone or in combination with a
             long-acting beta-2 Agonist [LABA]) for at least 3 months prior to the Screening Visit
             and must have been on a stable daily dose for at least 2 weeks prior to the Screening
             Visit

          -  FEV1 must be at least 70% predicted after all restricted medications have been
             withheld for the appropriate intervals

          -  Must demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after
             administration of 360 mcg albuterol (4 inhalations x 90 mcg, ex-actuator) or of
             nebulized albuterol (2.5 mg), if confirmed as standard office practice

        Exclusion Criteria:

          -  Has been treated in the emergency room for a severe asthma exacerbation requiring
             systemic glucocorticosteroid treatment, or hospitalized for management of airway
             obstruction within 3 months prior to the Screening Visit

          -  Has required ventilator support for respiratory failure secondary to asthma

          -  Demonstrates a decrease in absolute FEV1 of >20% at any time from the Screening Visit
             up to and including the Baseline Visit

          -  Requires the use of greater than 8 inhalations per day of short-acting beta-2 agonists
             (SABA) MDI, or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2
             consecutive days from the Screening Visit up to and including the Baseline Visit

          -  Experiences a clinical deterioration in asthma that results in emergency treatment,
             hospitalization due to asthma, or treatment with additional, excluded asthma
             medication (including oral or other systemic corticosteroids, but allowing SABA) as
             judged by the investigator, at any time from the Screening Visit up to and including
             the Baseline Visit