NCT00662779

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

Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exercise-induced Bronchospasm

Interventions

Type	Name	Description
DRUG	arformoterol	15 mcg arformoterol nebulizer
DRUG	formoterol	Formoterol 12 mcg/inhalation, dry powder inhaler
DRUG	placebo	placebo dry powder capsules ( lactose) and placebo normal saline for nebulization

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2008-04-21
• Last updated: 2015-12-11

Locations

1 site across 1 country: United States