Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2007-11-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment 1 then Treatment 2
Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.25mg
a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
Treatment 2 then Treatment 1
Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.25mg
a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
Treatment 3 then Treatment 4
Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.5mg
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Treatment 4 then Treatment 3
Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.5mg
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Interventions
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MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.25mg
a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.5mg
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 to 45 (up to the 46th birthday) years of age.
* Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria.
* Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits.
* Baseline FEV1 greater than or equal to 50% of predicted normal.
Exclusion Criteria
* A history of upper or lower respiratory tract infection within 2 weeks
* A history of acute or severe asthma attack requiring ICU admission or ventilatory support.
18 Years
45 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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West Coast Clinical Trials Phase 2-4, LLC
Long Beach, California, United States
Countries
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Related Links
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National Institutes of Health
Other Identifiers
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MAP0010-CL-P202
Identifier Type: -
Identifier Source: org_study_id
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