Official Title: “"Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."”

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.

Study Type: Interventional

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

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• Drug: montelukast vs pretreatment with albuterol
  • montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
• Drug: montelukast
  • Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise

Arms, Groups and Cohorts in this Clinical Trial

• Other: I
  • This is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication.

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of New Mexico

Overall Clinical Trial Officials and Contacts

Hengameh H Raissy, PharmD Principal Investigator University of New Mexico  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00273689

Study ID Number: ACCP

ClinicalTrials.gov Identifier: NCT00273689

Health Authority: United States: Institutional Review Board