A Phase 4 interventional study of montelukast vs pretreatment with albuterol and montelukast in Exercise Induced Bronchospasm, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2008-05-07.
Sponsored by University of New Mexico · Phase 4, Interventional, and Prevention
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.
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.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's enrollment of 13 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: montelukast
montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
Also known as: 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
Also known as: 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
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Montelukast