Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone furoate/formoterol fumarate (MFF); Formoterol fumarate 12 μg pMDI (F12M); Formoterol fumarate 12 μg DPI (F12D); Placebo to F12D; Placebo to F12M/MFF
Intervention description: Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.; Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).; Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).; Placebo to formoterol fumarate DPI delivered via DPI; Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Children; Persistent asthma

Summary:

      This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and
      duration of action), of a single dose of formoterol fumarate in combination with mometasone
      furoate to placebo in children of 5-11 years with persistent asthma. The study will also
      assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in
      combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI)
      to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler
      (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted
      throughout the study to assess systemic exposure following administration of the study
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  5 to 11 years of age of either sex and of any race

          -  A diagnosis (according to the Global Initiative for Asthma [GINA] guidelines) of
             persistent asthma for a period of at least 6 months prior to screening and must have
             been on a stable asthma regimen (daily dose unchanged) for at least 4 weeks prior to
             screening

          -  β2-agonist reversibility, defined as an increase in absolute FEV1 of ≥12% within 30
             minutes after administration of 200μg of salbutamol without the use of a spacer or its
             equivalent in accordance with ATS/ERS standards

          -  A child must have an FEV1 of ≥ 60% and ≤ 90% of Polgar predicted when all restricted
             medications have been withheld for the appropriate intervals

        Exclusion Criteria:

          -  Use of other investigational drugs at the time of enrolment, or within 30 days or 5
             half-lives of enrolment, whichever is longer.

          -  History of malignancy of any organ system within past 5 years.

          -  Pre-dose change (increase or decrease) in absolute FEV1 of 15% at Visit 2, compared
             with value at screening.

          -  Hospitalized or had an emergency room treatment for an acute asthma exacerbation in
             the 1 month prior to Visit 1, or who had a clinical deterioration of asthma between
             Visits 1 and 2 that resulted in emergency treatment, hospitalization, or treatment
             with excluded asthma medication.

          -  Significant medication condition or situation.

          -  QTc > 440 msec (boys) or > 450 msec (girls) on electrocardiogram(ECG) assessment at
             screening.

          -  Upper or lower respiratory tract infection within 4 weeks prior to screening.

          -  Chronic conditions affecting the respiratory tract or chronic lung diseases.