Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

Completed · Not applicable · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00359073

Run by

University of Wisconsin, Madison

People needed

25

Starts

2006-10-01

Expected to finish

2009-01-01

Last updated by the study team

2018-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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, to comply with directions and/or tolerate the procedures required for participation in this trial
• Pregnant or breast-feeding or has a planned pregnancy during the course of the study
• Regular use of an asthma controller such as montelukast or an inhaled corticosteroid.

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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