Clinical Trial: Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm
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 Summary:
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.
Sponsor: University of New Mexico
Current 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. [ Time Frame: April 2008-April 2010 ]
Original 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. [ Time Frame: April 2008-April 2009 ]
Current Secondary Outcome: Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler. [ Time Frame: April 2008- April 2010 ]
Original Secondary Outcome: Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler. [ Time Frame: April 2008- April 2009 ]
Information By: University of New Mexico
Dates:
Date Received: April 16, 2008
Date Started: April 2008
Date Completion:
Last Updated: December 9, 2015
Last Verified: December 2015
