Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273689
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2006-01-05
Brief Title:
Exercise Induced Bronchospasm in Children
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Pretreatment With Albuterol vs Montelukast in Exercise Induced Bronchospasm in Children
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None