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

• Status: Withdrawn
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Treatments: Formoterol Fumarate

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