Viral Infection in Asthma (VIA) Study
Eligible age
18–40 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this 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 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.
Sponsor: University of Virginia
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Charlottesville
Source: ClinicalTrials.gov · NCT04380038 · last updated 2025-04-01