Viral Infection in Asthma (VIA) Study

Viral Infection in Asthma (VIA) Study (NCT04380038) is a Phase 4 interventional studying Asthma, sponsored by University of Virginia. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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 Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Asthma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adult ages 18-40 2. Physician diagnosed asthma for at least 6 months 3. Mild persistent asthma well controlled (ACT≥20) over 6-month period prior to enrollment 4. FEV1 of \>80% predicted 5. Well controlled asthma on albuterol alone or albuterol plus low to medium dose inhaled corticosteroids (ICS) with or without other controller medications not using any anti-inflammatory medications for any concurrent sinonasal conditions. 6. Positive methacholine test (≤16 mg/ml) 7. Blood eosinophil count ≥150/µL or FeNO ≥20 ppb 8. Negative (≤1:4) serum neutralizing HRV antibody to HRV 16 or HRV 39. 9. Willing and able to comply with clinic visits and study-related procedures 10. Provide willing to sign a consent form signed by study patient 11. Able to understand and complete study-related questionnaires Who Should NOT Join This Trial: 1. Current smoker or has smoked regularly for 10 yrs and smoked \>10 pack-years 2. History or clinical evidence of COPD or any other significant lung disease 3. Known allergy to any ingredients in the study drug product 4. Asthma biologic therapy in last 3 months (including dupilumab) 5. Antiviral, immunosuppressive, or immune modulator therapies in the last 3 months 6. Use of any inhaled nasal sprays 7. Upper or lower respiratory tract infection in the last 6 weeks 8. Asthma exacerbation in the last 6 weeks 9. Any history of an asthma exacerbation requiring Emergency Department visit, intubation or hospitalization 10. History of asthma exacerbation requiring unscheduled office visit or oral corticosteroids within the past 3 years 11. Members of the clinical site study team and/or his/her immediate family 12. Pregnant or breastfeeding women 13. Women of childbearing potential\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last dose. Highly effective contraceptive measures include: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Adult ages 18-40 2. Physician diagnosed asthma for at least 6 months 3. Mild persistent asthma well controlled (ACT≥20) over 6-month period prior to enrollment 4. FEV1 of \>80% predicted 5. Well controlled asthma on albuterol alone or albuterol plus low to medium dose inhaled corticosteroids (ICS) with or without other controller medications not using any anti-inflammatory medications for any concurrent sinonasal conditions. 6. Positive methacholine test (≤16 mg/ml) 7. Blood eosinophil count ≥150/µL or FeNO ≥20 ppb 8. Negative (≤1:4) serum neutralizing HRV antibody to HRV 16 or HRV 39. 9. Willing and able to comply with clinic visits and study-related procedures 10. Provide informed consent signed by study patient 11. Able to understand and complete study-related questionnaires Exclusion Criteria: 1. Current smoker or has smoked regularly for 10 yrs and smoked \>10 pack-years 2. History or clinical evidence of COPD or any other significant lung disease 3. Known allergy to any ingredients in the study drug product 4. Asthma biologic therapy in last 3 months (including dupilumab) 5. Antiviral, immunosuppressive, or immune modulator therapies in the last 3 months 6. Use of any inhaled nasal sprays 7. Upper or lower respiratory tract infection in the last 6 weeks 8. Asthma exacerbation in the last 6 weeks 9. Any history of an asthma exacerbation requiring Emergency Department visit, intubation or hospitalization 10. History of asthma exacerbation requiring unscheduled office visit or oral corticosteroids within the past 3 years 11. Members of the clinical site study team and/or his/her immediate family 12. Pregnant or breastfeeding women 13. Women of childbearing potential\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last dose. Highly effective contraceptive measures include: 1. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening 2. intrauterine device (IUD); intrauterine hormone releasing system (IUS) 3. bilateral tubal ligation 4. vasectomized partner and/or  1. sexual abstinence†, ‡. * Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. * Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.

Treatments Being Tested

DRUG

Dupilumab Injectable Product

Nasal inoculation, single dose 300 TCID50 in 1ml.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Virginia

Charlottesville, Virginia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04380038), the sponsor (University of Virginia), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04380038 clinical trial studying?

Who can participate in NCT04380038?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04380038?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04380038. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04380038. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.