Viral Infection in Asthma (VIA) Study

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04380038
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2022
Status verified
Mar 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dupilumab
    The dupilumab dose regimen selected for this study (300 mg q2w after an initial loading dose of 600 mg)
  • Placebo Comparator: Placebo
    A harmless substance that looks like the study drug, but which should have no effect. The placebo formulation used in this study contains all the ingredients present in the active drug, except the active ingredient (IL-4α antibody). Therefore, the risk related to this formulation should be no greater than the risk associated to the active drug.

Primary Outcome Measure

Change in interleukin-25 transcript expression post-rhinovirus inoculation [ Time Frame: Day 0 to day 4 post-inoculation with the rhinovirus ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Deborah Murphy, BSN
[email protected]
434-982-3510
Larry Borish, MD
[email protected]
4349245779
Larry Borish, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
University of Virginia· Charlottesville, VA

Related Studies