A Study of 2 Doses of MAP0010 in Adult Asthmatics

Study Identifier
MAP0010-CL-P202
CT.gov Identifier
NCT00554970
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
  • MAP0010 low dose
  • MAP0010 high dose
  • Budesonide inhalation suspension 0.25mg
  • Budesonide inhalation suspension 0.5mg
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 45 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female adult asthmatics with mild to moderate persistent asthma. * 18 to 45 (up to the 46th birthday) years of age. * Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria. * Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits. * Baseline FEV1 greater than or equal to 50% of predicted normal.
    Exclusion Criteria:
    * Any other significant illness/abnormality * A history of upper or lower respiratory tract infection within 2 weeks * A history of acute or severe asthma attack requiring ICU admission or ventilatory support.

    Protocol Summary

    The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.

    Study Locations

    Location
    Status
    Location
    West Coast Clinical Trials Phase 2-4, LLC
    Long Beach, California, United States, 90806
    Status
    Not applicable