Exercise Induced Bronchospasm in Children

Condition(s) targeted: Exercise Induced Bronchospasm

Intervention: montelukast vs pretreatment with albuterol (Drug); montelukast (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of New Mexico

Official(s) and/or principal investigator(s):
Hengameh H Raissy, PharmD, Principal Investigator, Affiliation: University of New Mexico
William Kelly, PharmD, Study Director, Affiliation: University of New Mexico

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.

Official title: "Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study

Primary outcome: 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.

Secondary outcome: Additional objectives will be to compare the differences in response to montelukast with regard to LTB4 concentrations from EBC and FeNO level

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.

Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.

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

University of New Mexico, Albuquerque, New Mexico 87131, United States

Starting date: December 2005
Ending date: September 2007
Last updated: May 1, 2008