RecruitingPhase 4NCT04380038

Viral Infection in Asthma (VIA) Study


Sponsor

University of Virginia

Enrollment

60 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how a common cold virus (rhinovirus) affects people with mild, well-controlled asthma. Participants are intentionally exposed to rhinovirus in a controlled setting to study immune responses and the biology of asthma flare-ups triggered by respiratory infections. **You may be eligible if...** - You are between 18 and 40 years old - You have had a doctor's diagnosis of asthma for at least 6 months - Your asthma is mild and well-controlled (ACT score of 20 or more) - Your lung function is at least 80% of what's expected for your age and size - You have elevated inflammation markers in blood or breath (eosinophils or FeNO) - You do not have existing immunity to the specific rhinovirus strains used in this study **You may NOT be eligible if...** - You are a current smoker or have a significant smoking history - You have COPD or another major lung condition - You have used asthma biologic therapy (like dupilumab) in the last 3 months - You have had an asthma attack requiring emergency care or hospitalization at any point in your life - You had an asthma flare-up or respiratory infection in the last 6 weeks - You are pregnant or breastfeeding - You use nasal sprays of any kind Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab Injectable Product

Nasal inoculation, single dose 300 TCID50 in 1ml.


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT04380038


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