Exercise Induced Bronchospasm in Children
Condition: Exercise Induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 4

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 don't 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.
    

Intervention name(s): montelukast vs pretreatment with albuterol; montelukast
Intervention type(s): Drug; Drug
Intervention description(s): montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise; Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
Other intervention name(s): Singulair is the brand name for montelukast.; Brand name for montelukast: Singulair
Intervention MeSH terms: Albuterol; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention