Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma - Full Text View

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00359073

Purpose

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
Asthma	Drug: montelukast Drug: placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359073

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

James E Gern, MD

University of Wisconsin, Madison

More Information

Additional Information:

Allergy,Asthma and Pulmonary Clinical Research Unit website This link exits the ClinicalTrials.gov site

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kloepfer KM, DeMore JP, Vrtis RF, Swenson CA, Gaworski KL, Bork JA, Evans MD, Gern JE. Effects of montelukast on patients with asthma after experimental inoculation with human rhinovirus 16. Ann Allergy Asthma Immunol. 2011 Mar;106(3):252-7. Epub 2011 Jan 13.

Responsible Party:	James Gern, MD, University Of Wisconsin
ClinicalTrials.gov Identifier:	NCT00359073 History of Changes
Other Study ID Numbers:	31799
Study First Received:	July 28, 2006
Last Updated:	February 17, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

asthma
leukotrienes
rhinovirus

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012