Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma (NCT00359073) | Clinical Trial Compass
CompletedNot Applicable
Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma
United States25 participantsStarted 2006-10
Plain-language summary
People with asthma may have asthma worsening when they have an upper respiratory infection due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung inflammation. Experimental virus exposure in adults is also associated with increases in nasal leukotrienes.
The degree to which leukotrienes play a role in asthma worsening is unknown.There is information linking leukotrienes to viral infections, allergic inflammation, and asthma exacerbation.This information supports the hypothesis that virus-induced leukotrienes contribute to the severity of respiratory infections and in susceptible individuals, lead to lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an experimental viral challenge model to explore this hypothesis.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A subject with mild persistent asthma is eligible for participation in the study if all of the following inclusion criteria apply:
* Male or female with no health concerns that might affect the outcome of the study
* Age 18-65 range
* diagnosis of mild persistent asthma based on clinical findings such as cough, wheeze and shortness of breath
* a history of asthma for at least six months prior to screening
* FEV1\> 80% of predicted
* presence of allergy based on at least one positive prick skin test when tested with a standard panel of common allergens
* ability to produce sputum when induced during the baseline assessments
* asthma medications consisting of only inhaled short acting B-agonist taken as needed
* reversible airways disease as indicated by \> 12% reversibility post B-agonist or
* methacholine hyperresponsiveness (PC20 \< 8 mg/ml)
* ability to give valid informed consent to participate by signing and dating a written consent form
Exclusion Criteria:
A subject is not eligible to participate in this study if any of the following exclusion criteria apply:
* History of severe episodes of asthma with respiratory infections
* Screening serum RV16 antibody titer \> 1
* Current smoker or has a smoking history exceeding 5 pack years
* Currently receiving immunotherapy
* Currently participating in another clinical trial or has participated in an investigational drug trial within one month of screening
* Unable, in the judgment of the investigator, t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.