Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma
Overview[ - collapse ][ - ]
| 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 | Asthma |
| Intervention | Drug: montelukast Drug: placebo |
| Phase | N/A |
| Sponsor | University of Wisconsin, Madison |
| Responsible Party | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier | NCT00359073 |
| First Received | July 28, 2006 |
| Last Updated | February 17, 2009 |
| Last verified | February 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 28, 2006 |
|---|---|
| Last Updated Date | February 17, 2009 |
| Start Date | October 2006 |
| Estimated Primary Completion Date | January 2009 |
| Current Primary Outcome Measures | Infection related change in asthma control [Time Frame: acute infection vs 7 days prior to inoculation] [Designated as safety issue: No] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma |
|---|---|
| Official Title | Effect of Montelukast on Experimentally-Induced RV16 Infection in Volunteers With Mild Asthma |
| Brief 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition | Asthma |
| Intervention | Drug: montelukast 10 mg QD Other Names: SingulairDrug: placebo like placebo Other Names: like placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 20 |
| Estimated Completion Date | January 2009 |
| Estimated Primary Completion Date | January 2009 |
| Eligibility 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00359073 |
|---|---|
| Other Study ID Numbers | 31799 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Wisconsin, Madison |
| Study Sponsor | University of Wisconsin, Madison |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: James E Gern, MD University of Wisconsin, Madison |
| Verification Date | February 2009 |
Locations[ + expand ][ + ]
| University of Wisconsin | Madison, Wisconsin, United States, 53792 |
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