Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Exercise-induced Bronchospasm

In brief

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.

Key facts

Study ID: NCT00662779
Run by: University of New Mexico
People needed: 0
Starts: 2008-04-01
Expected to finish: 2009-07-01
Last updated by the study team: 2015-12-11

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of New Mexico — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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