A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

Study Identifier
MAP0010-CL-P301
CT.gov Identifier
NCT00569192
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Asthma
    • Study Drug
  • 0.135mg MAP0010
  • 0.25mg MAP0010
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12 Months - 8 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female asthmatic children with mild to moderate persistent asthma. * 12 months to 8 years of age. * For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria. * For infants age 12 to \<48 months old: 2 or more wheezing episodes in past 12 months which lasted \> 1 day and affected sleep. * AND with at least one major or two minor risk factors.
    Exclusion Criteria:
    * Any other significant childhood illness/abnormality or chronic lung disease * Any history of upper or lower respiratory tract infection, within 2 weeks of screening. * Any history of acute or severe asthma attack requiring ICU admission or ventilatory support. * Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening. * Any use of oral corticosteroids within 30 days of screening or prolonged use (\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

    Protocol Summary

    The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

    Study Locations

    No locations found.