Study of MAP0010 in Asthmatic Children and Adolescents

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Collaborator: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Any other significant childhood illness.

• Participated in any investigational clinical trial within the 30 days prior to screening.

• 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 support.

• History suggestive (or diagnosis) of other concomitant lung disease.