Viewing Study NCT00359073



Ignite Creation Date: 2024-05-05 @ 4:58 PM
Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00359073
Status: COMPLETED
Last Update Posted: 2018-03-13
First Post: 2006-07-28

Brief Title: Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma
Sponsor: University of Wisconsin Madison
Organization: University of Wisconsin Madison

Study Overview

Official Title: Effect of Montelukast on Experimentally-Induced RV16 Infection in Volunteers With Mild Asthma
Status: COMPLETED
Status Verified Date: 2018-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 unknownThere is information linking leukotrienes to viral infections allergic inflammation and asthma exacerbationThis 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 however one problem with this approach is that once the clinical signs and symptoms appear viral replication is well underway

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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
31799 OTHER PI None