Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
NCT ID: NCT00308685
Last Updated: 2022-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
95 participants
INTERVENTIONAL
2006-06-10
2006-12-04
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
QUADRUPLE
Study Groups
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Albuterol-HFA-BAI
ProAir(TM) HFA, Breath Actuated Inhalation Aerosol
Albuterol
Albuterol 90mcg
Placebo-HFA-BAI
Placebo
Placebo
Placebo
Interventions
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Albuterol
Albuterol 90mcg
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
* Ability to perform spirometry
* Demonstrate 12% airways reversibility
Exclusion Criteria
* Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
4 Years
11 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, M.D.
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Little Rock Allergy and Asthma
Little Rock, Arkansas, United States
Allergy & Asthma Specialist Medical Group
Huntington Beach, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
William Storms Medical Research
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States
Colorado Allergy and Asthma Centers, PC
Lakewood, Colorado, United States
Southern Allergy & Asthma, PC
Savannah, Georgia, United States
Sneeze, Wheeze & Itch Associates, Inc.
Normal, Illinois, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
The Asthma & Allergy Center, PC
Papillion, Nebraska, United States
Allergy and Respiratory Center
Canton, Ohio, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Pediatric Pulmonary Associates of North Texas
Dallas, Texas, United States
Countries
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Other Identifiers
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IXR-303-25-167
Identifier Type: -
Identifier Source: org_study_id
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