Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
Phase 3
Withdrawn
- Conditions
- Exercise-induced Bronchospasm
- Interventions
- Registration Number
- NCT00662779
- Lead Sponsor
- University of New Mexico
- 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 regimen.
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 3 placebo 1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer 1 arformoterol 15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder 2 formoterol 1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer
- Primary Outcome Measures
Name Time Method 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. April 2008-April 2010
- Secondary Outcome Measures
Name Time Method Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler. April 2008- April 2010
Trial Locations
- Locations (1)
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States