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

Phase 3

Registration Number: CTRI/2011/091/000069

Lead Sponsor: MAP Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

*Male or female asthmatic children with mild to moderate persistant 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the change from baseline in nighttime and daytime composite symptom scores.Timepoint: Time Frame: Prospective

Secondary Outcome Measures

Name	Time	Method
To evaluate e-diary symptoms (cough, wheeze, breathlessness)Timepoint: Time frame: prospective;To evaluate lung function (PEF)Timepoint: Time Frame: Prospective;To evaluate the change in clinic FEV1 from baseline.Timepoint: Time Frame: Prospective