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NCT04380038 · ClinicalTrials.gov registry record · Phase 4

Viral Infection in Asthma (VIA) Study

A Phase 4 study of Asthma, sponsored by University of Virginia.

Recruiting
Registry status
Phase 4
Development phase
60
Enrollment target
1
Study location

NCT04380038 is a Phase 4 study of Asthma that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 60 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04380038, a Phase 4 study of Asthma, is actively recruiting participants, sponsored by University of Virginia.

RECRUITING
Registry status
Phase 4
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Asthma

Interventions

  • DRUG Dupilumab Injectable Product

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-05-01
Est. Completion 2026-12-31
Phase Phase 4

Sponsor

University of Virginia

449 total trials

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What the Registry Record Tells You About NCT04380038

The ClinicalTrials.gov registry entry for NCT04380038 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab Injectable Product is the first listed.

NCT04380038 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT04380038 about?

NCT04380038 is a clinical study titled "Viral Infection in Asthma (VIA) Study". 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 asthm...

What is the current status of trial NCT04380038?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2022-05-01. Estimated completion is 2026-12-31.

What conditions does trial NCT04380038 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT04380038?

The interventions under investigation include: Dupilumab Injectable Product (DRUG).

Who is sponsoring clinical trial NCT04380038?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04380038 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.