The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics
of 2 doses of MAP0010 in asthmatic children/adolescents.
This is a randomized, double blind, placebo controlled, 3 arm, parallel group, phase 2 study
of MAP0010(UDB)in asthmatic children.
Subjects who meet the study entrance criteria will be randomized to one of three treatment
groups and receive their first and selected other doses under supervision in the clinic.
All subjects will complete 6 weeks of dosing, with diary card data collection throughout and
clinic lung function tests (in children of appropriate age and ability) at start, during and
end of study treatment period.
- Male or female asthmatic children/adolescents
- 1 to 18 years of age
- FEV1 greater than or equal to 50% predicted normal (where obtainable)
- Stable but symptomatic
- Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR
documented exacerbation or worsening of asthma or symptoms suggestive of asthma
including nocturnal asthma, within 6 months of screening OR documented SAB use more
than or at least once for symptom relief during the 4 days of run in with a total
symptom score greater than or equal to 1 OR greater than or equal to 1 night
disturbed due to asthma symptoms in previous month.
- Any other significant childhood illness.
- Participated in any investigational clinical trial within the 30 days prior to
- Use of any corticosteroid within 2 weeks of screening.
- Use of oral corticosteroid within 30 days of screening or prolonged use of oral
corticosteroids within 12 weeks of screening.
- Use of inhaled long acting bronchodilators.
- Presumptive or documented history of upper or lower respiratory infection within 2
weeks before screening.
- Any history of acute or severe asthma attack requiring ICU admission or ventilatory
- History suggestive (or diagnosis) of other concomitant lung disease.