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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: Recruiting Phase 4 study of Asthma, sponsored by University of Virginia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of the change in IL-25 transcript expression in nasal scraping samples as determined by semi-quantitative polymerase chain reaction between the placebo- and dupilumab-treated cohorts
Conditions Studied
Interventions
- DRUG Dupilumab Injectable Product
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What NCT04380038 shows while recruiting
NCT04380038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04380038's enrollment target sits among peer trials
60 248th of 374 higher than 121 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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