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Exercise Induced Bronchospasm in Children

Primary Purpose

Exercise Induced Bronchospasm

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
montelukast vs pretreatment with albuterol
montelukast
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise Induced Bronchospasm

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

I

Arm Description

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

Outcomes

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.

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

Full Information

First Posted
January 5, 2006
Last Updated
May 1, 2008
Sponsor
University of New Mexico
Collaborators
American College of Clinical Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT00273689
Brief Title
Exercise Induced Bronchospasm in Children
Official Title
"Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children."
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of New Mexico
Collaborators
American College of Clinical Pharmacy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Induced Bronchospasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Other
Arm Description
This is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication.
Intervention Type
Drug
Intervention Name(s)
montelukast vs pretreatment with albuterol
Other Intervention Name(s)
Singulair is the brand name for montelukast.
Intervention Description
montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
Intervention Type
Drug
Intervention Name(s)
montelukast
Other Intervention Name(s)
Brand name for montelukast: Singulair
Intervention Description
Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hengameh H Raissy, PharmD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Kelly, PharmD
Organizational Affiliation
University of New Mexico
Official's Role
Study Director
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

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Exercise Induced Bronchospasm in Children

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