Exercise Induced Bronchospasm in Children | RxWiki

Exercise Induced Bronchospasm in Children

Overview[ - collapse ][ - ]

Purpose	The purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.
Condition	Exercise Induced Bronchospasm
Intervention	Drug: montelukast vs pretreatment with albuterol Drug: montelukast
Phase	Phase 4
Sponsor	University of New Mexico
Responsible Party	University of New Mexico
ClinicalTrials.gov Identifier	NCT00273689
First Received	January 5, 2006
Last Updated	May 1, 2008
Last verified	May 2008

Tracking Information[ + expand ][ + ]

First Received Date	January 5, 2006
Last Updated Date	May 1, 2008
Start Date	December 2005
Estimated Primary Completion Date	September 2007
Current Primary Outcome Measures	The primary outcome will be the comparison of the effect of inhaled albuterol and oral montelukast on EIB as percent attenuation in FEV1 after exercise challenge. [Time Frame: Fall in FEV1 immediately after exercise] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Additional objectives will be to compare the differences in response to montelukast with regard to LTB4 concentrations from EBC and FeNO level [Time Frame: immediately after exercise] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Exercise Induced Bronchospasm in Children
Official Title	"Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."
Brief Summary	The purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.
Detailed Description	TThis is a randomized, crossover, placebo controlled trial of 30 patients, 7-17 years old with confirmed EIB. Patients will be randomized to montelukast treatment for at least 3 days or pretreatment with albuterol before an exercise challenge. Villiran and colleagues have shown that the protective effect of montelukast in treating EIB is apparent at day 3 of treatment and comparable to treatment for 4 and 8 weeks. It is our hypothesis that pretreatment with albuterol will provide superior protection against breakthrough EIB in children with mild asthma compared to montelukast as maintenance therapy added to the current asthma regimen. Secondary aims of this study are to measure the effect of montelukast on leukotriene B4 (LTB4) concentrations as measured in EBC, and on inflammation measured by FeNO level. We hypothesize that since montelukast is a cysteinyl leukotriene receptor antagonist, patients with elevated concentration of LTB4 may have a greater response to this medication. Lastly, patients with elevated FeNO, a measure of airway inflammation respond differently to albuterol than montelukast his study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 4 study visits and last up to 3 weeks. Thirty children 7-17 years of age with asthma and EIB, regardless of current asthma therapy will be eligible for this trial. Patients will receive 3-7 days of therapy with either montelukast (5mg or 10 mg capsule) or placebo tablets. After 3-7 days of therapy the patients will be crossed over to receive the alternative therapy. Exercise challenges will be completed at screening, baseline, visit 3 and visit 4. All patients will have an albuterol metered-dose inhaler (MDI) to be used on an as needed basis for asthma symptoms.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Condition	Exercise Induced Bronchospasm
Intervention	Drug: montelukast vs pretreatment with albuterol montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise Other Names: Singulair is the brand name for montelukast.Drug: montelukast Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise Other Names: Brand name for montelukast: Singulair
Study Arm (s)	Other: I This is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	13
Estimated Completion Date	September 2007
Estimated Primary Completion Date	September 2007
Eligibility Criteria	Inclusion Criteria: - Children 7-17 years of age - Physician diagnosed asthma for at least 6 months - EIB diagnosed by a positive exercise challenge at screening and baseline visits - Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted at screening and baseline visit Exclusion Criteria: - History of cardiac dysfunction - Unable to perform exercise challenge - Use of montelukast
Gender	Both
Ages	7 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00273689
Other Study ID Numbers	ACCP
Has Data Monitoring Committee	Yes
Information Provided By	University of New Mexico
Study Sponsor	University of New Mexico
Collaborators	American College of Clinical Pharmacy
Investigators	Principal Investigator: Hengameh H Raissy, PharmD University of New MexicoStudy Director: William Kelly, PharmD University of New Mexico
Verification Date	May 2008

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