Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
Information source: University of New Mexico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exercise-induced Bronchospasm
Intervention: arformoterol (Drug); formoterol (Drug); placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: University of New Mexico Official(s) and/or principal investigator(s):
Hengameh Raissy, Pharm.D., Principal Investigator, Affiliation: University of New Mexico- Pediatric department
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 regimen.
Our secondary hypothesis is that nebulized arformoterol has comparable protection against
EIB compared to inhaled formoterol by dry powder inhaler.
Clinical Details
Official title: Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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 regimen.
Secondary outcome: Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
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 EIB, regardless of current asthma
therapy will be eligible for this trial.
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
University of New Mexico, Albuquerque, New Mexico 87107, United States
Additional Information
Starting date: April 2008
Last updated: August 16, 2011
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