NCT04380038: VIA

Viral Infection in Asthma (VIA) Study

Recruiting now Phase 4 Last updated 1 April 2025

What this trial tests

Phase 4 trial testing Dupilumab Injectable Product in Asthma in 60 participants. Currently enrolling.

Timeline

1 May 2022

Primary endpoint
30 June 2026

31 December 2026

Quick facts

Lead sponsor	University of Virginia
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 May 2022
Primary completion	30 June 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Dupilumab Injectable Product — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

University of Virginia

Who can join

Adults 18 to 40, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Often when people with asthma get a virus caused by the common cold (rhinovirus), they also experience an increase or worsening of their asthma symptoms. The purpose of this study is to see if the study medication dupilumab helps prevent those with mild to moderate asthma from having increased asthma symptoms, after being exposed to an experimental rhinovirus inoculation. This is a study about dupilumab which is a drug approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate to severe asthma. Dupilumab is a medication that blocks pathways that cause asthmatic inflammation in the lungs, leading to symptoms and worsening lung function. During this study, subjects will be given either dupilumab or placebo and will subsequently be exposed to the the "common" cold virus (rhinovirus). The virus that the investigators are using has been safely used before in many studies like this involving thousands of volunteers, and the safe use of the virus in this research study has been reviewed by the FDA. The investigators will track asthma symptoms during the study with lung function tests, questionnaires, specimen collection, biomarkers, and physical exams. For data analysis the investigators will assess the samples collected to determine changes in the treatment groups. The investigators will also asses the symptom scores and deviations from baseline measures for lung function.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. T-helper 2 mechanisms involved in human rhinovirus infections and asthma.
   Price AS, Kennedy JL. · · 2022 · cited 8× · PMID 36002092 · DOI 10.1016/j.anai.2022.08.015