Status:
COMPLETED
Study of MAP0010 in Asthmatic Children and Adolescents
Lead Sponsor:
Allergan
Collaborating Sponsors:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Conditions:
Asthma
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00697801
Start Date
July 1 2006
End Date
December 1 2006
Last Update
January 9 2014
Active Locations (1)
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1
San Diego, California, United States