Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2006-07-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Placebo
Placebo delivered by nebulization twice daily for 6 weeks
Placebo
Placebo delivered by nebulization twice daily for 6 weeks
Interventions
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MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Placebo
Placebo delivered by nebulization twice daily for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
18 Years
ALL
No
Sponsors
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MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
INDUSTRY
Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Locations
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San Diego, California, United States
Countries
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Other Identifiers
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MAP0010-CL-P201
Identifier Type: -
Identifier Source: org_study_id
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