Status:
WITHDRAWN
Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
Lead Sponsor:
University of New Mexico
Conditions:
Exercise-induced Bronchospasm
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regi...
Detailed Description
This study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 5 study visits and will last up to 3 weeks. Fifteen children 12-17 years of age with asthma and ...
Eligibility Criteria
Inclusion
- Children 12-17 years of age
- Physician diagnosed asthma for at least 6 months
- Long term controller medication for at least 4 weeks if any being used
- Females of child-bearing potential agree to use an acceptable form of birth control for the duration of the study
- EIB diagnosed by a positive exercise challenge at screening
- Forced expiratory volume in 1 second (FEV1) greater than 70% of predicted at screening visit
Exclusion
- History of cardiac dysfunction
- Inability to perform exercise challenge ( i.e., running on treadmill or performing adequate spirometry)
- Upper respiratory infection in the last 4 weeks
- Severe exacerbation, use of oral steroids, or hospitalization in the last 3 months
- Chronic (greater than 2 weeks) use of a Long Acting Beta Agonist (LABA)
- Pregnancy or lactation
- History of paradoxical bronchospasm with any beta-agonist
- Obesity defined as BMI greater than 30 kg/m2
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00662779
Start Date
April 1 2008
End Date
July 1 2009
Last Update
December 11 2015
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87107