Exercise Induced Bronchospasm in Children
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|ClinicalTrials.gov Identifier: NCT00273689|
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : May 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Exercise Induced Bronchospasm||Drug: montelukast vs pretreatment with albuterol Drug: montelukast||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||"Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
This is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication.
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 Name: Singulair is the brand name for montelukast.
Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
Other Name: Brand name for montelukast: Singulair
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273689
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Hengameh H Raissy, PharmD||University of New Mexico|
|Study Director:||William Kelly, PharmD||University of New Mexico|