Exercise Induced Bronchospasm in Children

This study has been completed.
Sponsor:
Collaborator:
American College of Clinical Pharmacy
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00273689
First received: January 5, 2006
Last updated: May 1, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Exercise Induced Bronchospasm
Drug: montelukast vs pretreatment with albuterol
Drug: montelukast
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: "Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: December 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273689

Locations
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
Investigators
Principal Investigator: Hengameh H Raissy, PharmD University of New Mexico
Study Director: William Kelly, PharmD University of New Mexico
  More Information

No publications provided

Responsible Party: Hengameh Raisyy, Pharm.D., University of New Mexico
ClinicalTrials.gov Identifier: NCT00273689     History of Changes
Other Study ID Numbers: ACCP
Study First Received: January 5, 2006
Last Updated: May 1, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Montelukast
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 17, 2014