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

Exercise-induced Bronchospasm Clinical Trial

— EIB  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00662779
• Other study ID #: ASRC948
• Secondary ID: 5-MO1-RR-00997
• Status: Withdrawn
• Phase: Phase 3
• First received: April 16, 2008
• Last updated: December 9, 2015
• Start date: April 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2015
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Bronchial Spasm
• Exercise-induced Bronchospasm

Intervention

Drug:
• arformoterol
15 mcg arformoterol nebulizer
• formoterol
Formoterol 12 mcg/inhalation, dry powder inhaler
• placebo
placebo dry powder capsules ( lactose) and placebo normal saline for nebulization

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.		April 2008- April 2010	Yes