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| Sponsor: | University of New Mexico |
|---|---|
| Collaborator: |
American College of Clinical Pharmacy |
| Information provided by: | University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT00273689 |
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 IV |
| 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." |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| Principal Investigator: | Hengameh H Raissy, PharmD | University of New Mexico |
| Study Director: | William Kelly, PharmD | University of New Mexico |
More Information
| 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 |
|
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 |
