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

Sponsor

University of New Mexico (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00662779

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise-induced Bronchospasm	Drug: arformoterol Drug: formoterol Drug: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder	Drug: arformoterol 15 mcg arformoterol nebulizer Other Names: Brand name is Brovana.
Active Comparator: 2 1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer	Drug: formoterol Formoterol 12 mcg/inhalation, dry powder inhaler Other Names: Brand name is Foradil
Placebo Comparator: 3 1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer	Drug: placebo placebo dry powder capsules ( lactose) and placebo normal saline for nebulization

Arm

Intervention/Treatment

Experimental: 1

15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder

Drug: arformoterol

15 mcg arformoterol nebulizer

Other Names:

Brand name is Brovana.

Active Comparator: 2

1 inhalation of formoterol fumarate inhalation powder (12 mcg/inhalation) + 2 ml of normal saline nebulizer

Drug: formoterol

Formoterol 12 mcg/inhalation, dry powder inhaler

Other Names:

Brand name is Foradil

Placebo Comparator: 3

1 inhalation of placebo inhalation powder + 2 ml of normal saline nebulizer

Drug: placebo

placebo dry powder capsules ( lactose) and placebo normal saline for nebulization

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler. [April 2008- April 2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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