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Exercise Induced Bronchospasm in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00273689
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : May 7, 2008
American College of Clinical Pharmacy
Information provided by:
University of New Mexico

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 don't know which medicine is better at stopping asthma symptoms caused by exercising.

Condition or disease Intervention/treatment Phase
Exercise Induced Bronchospasm Drug: montelukast vs pretreatment with albuterol Drug: montelukast Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: "Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."
Study Start Date : December 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
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
montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
Other Name: Singulair is the brand name for montelukast.

Drug: montelukast
Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
Other Name: Brand name for montelukast: Singulair

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00273689

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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
American College of Clinical Pharmacy
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Principal Investigator: Hengameh H Raissy, PharmD University of New Mexico
Study Director: William Kelly, PharmD University of New Mexico
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Responsible Party: Hengameh Raisyy, Pharm.D., University of New Mexico Identifier: NCT00273689    
Other Study ID Numbers: ACCP
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008
Additional relevant MeSH terms:
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Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents