Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
13 participants
INTERVENTIONAL
2005-12-31
2007-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
I
This is a crossover trial- Patients get randomly assign to albuterol or singulair and then cross overed to the alternate active medication.
montelukast vs pretreatment with albuterol
montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
montelukast
Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
montelukast vs pretreatment with albuterol
montelukast 5 or 10 mg once daily for 3 days vs albuterol 2 puffs, 15 minutes before exercise
montelukast
Montelukast 5 or 10 mg once daily for 3 days vs Albuterol inhlare 2 puffs, 15 minutes before exercise
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Unable to perform exercise challenge
* Use of montelukast
7 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
American College of Clinical Pharmacy
OTHER
University of New Mexico
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of New Mexico
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hengameh H Raissy, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
William Kelly, PharmD
Role: STUDY_DIRECTOR
University of New Mexico
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of New Mexico
Albuquerque, New Mexico, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACCP
Identifier Type: -
Identifier Source: org_study_id