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

Sponsor:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00662779

Purpose

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	Intervention	Phase
Exercise-Induced Bronchospasm	Drug: arformoterol Drug: formoterol Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Bronchoprotective Effect of Arformoterol in Children With Exercise Induced Bronchospasm

Resource links provided by NLM:

MedlinePlus related topics: Asthma Exercise and Physical Fitness

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by University of New Mexico:

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. [ Time Frame: April 2008-April 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler. [ Time Frame: April 2008- April 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 15 mcg arformoterol nebulizer + 1 inhalation of placebo inhalation powder	Drug: arformoterol 15 mcg arformoterol nebulizer
2: Active Comparator 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
3: Placebo Comparator 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

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.

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662779

Contacts

Contact: Hengameh Raissy, Pharm.D.	505-272-5484	hheidarian-raissy@salud.unm.edu
Contact: William Kelly, Pharm.D.	505-272-3658	Hwkelly@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico	Recruiting
Albuquerque, New Mexico, United States, 87107
Contact: Fran Kelly, BS 505-272-9889 FMKelly@salud.unm.edu
Contact: Hengameh Raissy, Pharm.D. 505-272-5484 hheidarian-raissy@salud.unm.edu
Principal Investigator: Hengameh Raissy, Pharm.D.
Sub-Investigator: William Kelly, Pharm.D.
Sub-Investigator: Michelle Harkins, MD
Sub-Investigator: Lea Davies, MD

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Hengameh Raissy, Pharm.D.

University of New Mexico- Pediatric department

More Information

No publications provided

Responsible Party:	School of Medicine, University of New Mexico ( Hengameh H. Raissy, Pharm.D. )
Study ID Numbers:	ASRC948, 5-MO1-RR-00997
Study First Received:	April 16, 2008
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00662779 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of New Mexico:

asthma
exercise induced bronchospasm
prevention
EIB
children

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Spasm
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Adrenergic Agonists
Asthma, Exercise-Induced
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Hypersensitivity, Immediate
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 05, 2009