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AsthmaLungs and breathingDrugPhase 4

What this study is

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.

What's being tested

  • Dupilumab Injectable Product

    Intervention · DRUG

    Nasal inoculation, single dose 300 TCID50 in 1ml.

Study details

Sponsor
University of Virginia
Conditions
Asthma
Enrolling
60 people
Starts
2022-05-01
Est. completion
2026-12-31
Design
Quadruple-blind, randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗