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Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

This study has been completed.
Information provided by:
University of Wisconsin, Madison Identifier:
First received: July 28, 2006
Last updated: February 17, 2009
Last verified: February 2009

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.

Condition Intervention
Drug: montelukast
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Montelukast on Experimentally-Induced RV16 Infection in Volunteers With Mild Asthma

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Infection related change in asthma control [ Time Frame: acute infection vs 7 days prior to inoculation ]

Secondary Outcome Measures:
  • Secondary outcome measures include cold symptoms, viral shedding and cellularity in the nasal secretions and induced sputum. [ Time Frame: acute infection vs 7 days prior to inoculation ]

Enrollment: 20
Study Start Date: October 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
montelukast (10 mg QD)
Drug: montelukast
10 mg QD
Other Name: Singulair
Placebo Comparator: 2 Drug: placebo
like placebo
Other Name: like placebo

Detailed Description:
Viral infections are important causes of wheezing illnesses throughout childhood and in adults with asthma. There has been progress in identifying mechanisms and risk factors for severe respiratory symptoms, and in particular, wheezing. Given this close relationship, it would be attractive to apply antiviral strategies to the prevention and treatment of asthma, and both RV and RSV are obvious targets. Unfortunately, attempts at developing an RSV vaccine have so far been unsuccessful, and vaccination to prevent RV infection does not seem to be feasible due to the large number of serotypes. Antiviral medications have been tested in clinical trials,53-57 however one problem with this approach is that once the clinical signs and symptoms appear, viral replication is well underway. As a result, reductions in respiratory symptoms or the duration of illness are modest.56 The other potential therapeutic approach for respiratory viral infections would be to selectively inhibit pro-inflammatory immune responses induced by the virus. The beneficial effects of systemic glucocorticoids indicate that this approach is valid; the challenge will be to develop treatments with greater efficacy and a reduced potential for adverse effects. The large body of information linking cysteinyl leukotrienes to viral infections, allergic inflammation, and asthma exacerbations, strongly 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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, 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.
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Please refer to this study by its identifier: NCT00359073

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: James E Gern, MD University of Wisconsin, Madison
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: James Gern, MD, University Of Wisconsin Identifier: NCT00359073     History of Changes
Other Study ID Numbers: 31799
Study First Received: July 28, 2006
Last Updated: February 17, 2009

Keywords provided by University of Wisconsin, Madison:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017