Actively Recruiting

Phase 4
Age: 18Years - 40Years
All Genders
NCT04380038

Viral Infection in Asthma (VIA) Study

Led by University of Virginia · Updated on 2025-04-01

60

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

Sponsors

U

University of Virginia

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Viral Infection in Asthma (VIA) Study

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 40 years
  • Physician diagnosed asthma for at least 6 months
  • Mild persistent asthma well controlled (ACT≥20) over 6 months before enrollment
  • FEV1 greater than 80% predicted
  • Well controlled asthma using albuterol alone or albuterol plus low to medium dose inhaled corticosteroids with or without other controllers, and no anti-inflammatory meds for sinonasal conditions
  • Positive methacholine test (≤16 mg/ml)
  • Blood eosinophil count ≥150/μL or FeNO ≥20 ppb
  • Negative serum neutralizing antibody to HRV 16 or HRV 39 (≤1:4)
  • Willing and able to comply with clinic visits and study procedures
  • Signed informed consent
  • Able to understand and complete study questionnaires
Not Eligible

You will not qualify if you...

  • Current smoker or history of regular smoking for 10 years with more than 10 pack-years
  • History or signs of COPD or other significant lung diseases
  • Known allergy to any ingredient in the study drug
  • Use of asthma biologic therapy, including dupilumab, in the last 3 months
  • Use of antiviral, immunosuppressive, or immune modulator therapies in the last 3 months
  • Use of any inhaled nasal sprays
  • Upper or lower respiratory tract infection in the last 6 weeks
  • Asthma exacerbation in the last 6 weeks
  • History of asthma exacerbation requiring emergency visit, intubation, or hospitalization
  • Asthma exacerbation requiring unscheduled office visit or oral corticosteroids in past 3 years
  • Members of the clinical study team or immediate family
  • Pregnant or breastfeeding women
  • Women of childbearing potential unwilling to use highly effective contraception during and after the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

K

Kristin W Wavell Shifflett, BS, CCRC

CONTACT

D

Deborah Murphy, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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