NCT02910401

Clinical Response to Rhinovirus Challenge

Clinical Response to Rhinovirus Challenge in Human Asthmatics

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Rhinovirus (RV) infections represent the most common cause of asthma exacerbations in children and adolescents. The investigators hypothesize that the immune responses generated in the nose of allergic rhinitics and asthmatics underlie subsequent systemic modulation of the immune system, and that - in susceptible individuals (i.e., those with pre-existing asthma) - this modified nasal milieu is responsible for the asthma exacerbation. Open label single center study in asthmatics as well as allergic rhinitis (AR) and healthy controls. All subjects will undergo good manufacturing practice (GMP) RV16 inoculation and responses will be compared between the 3 cohorts.

Detailed description

Primary objectives are: To determine whether RV increases expression of interleukin (IL)-25 transcripts by nasal epithelial cells in the asthma and AR but not control cohorts at the peak of infection (days 3 and 4). To determine whether RV increases lower respiratory symptoms in the asthma but not AR and control cohorts. To determine whether asthmatics and allergic rhinitics will demonstrate an increased severity of infection in comparison to control subjects. Secondary objectives are: 1. To determine whether asthmatic and AR cohorts demonstrate increased IL-25 transcript expression over the course of RV infection 2. To determine whether asthmatic and AR cohorts demonstrate increased expression of mRNA transcripts of a type 2 cytokine-inducing profile (IL-33 and thymic stromal lymphopoietin (TSLP)). 3. To determine whether increased transcript expression of this type 2 cytokine-inducing profile can be corroborated as increased expression of protein. 4. To determine whether RV infection in the asthma cohort is associated with increases in biomarkers of inflammation. 5. To determine whether increased severity of RV infection in the asthma and AR cohorts will be associated with more symptoms. 6. To determine whether increased severity of RV infection in the asthma and AR cohorts is related to decreased innate immunity.

Conditions

• Asthma
• Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	Rhinovirus (GMP RV16 HRV-16)	300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2016-09-22
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

1 site across 1 country: United States