CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Rhinovirus (GMP RV16 HRV-16)biological
Likely dose
Rhinovirus (GMP RV16 HRV-16) 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02910401
NCT02910401Phase 2Completed

Clinical Response to Rhinovirus Challenge in Human Asthmatics

University of Virginia·interventional·Posted Sep 22, 2016·Updated Jan 9, 2024

In Brief

A Phase 2 clinical trial evaluating Rhinovirus (GMP RV16 HRV-16) for Asthma and Allergic Rhinitis. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 22, 2016
Enrollment StartSep 1, 2016
Primary CompletionSep 21, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 9.8 years ago

Interventions

Rhinovirus (GMP RV16 HRV-16)biological

300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only