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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Exercise-induced Bronchospasm

Intervention / Treatment
-----------------
* Drug: arformoterol
* Drug: formoterol
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler. |  | April 2008- April 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EIB, asthma, exercise induced bronchospasm, prevention, children