Dupilumab for Asthma
(VIA Trial)
Trial Summary
What is the purpose of 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.
Do I need to stop taking my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used asthma biologic therapy, antiviral, immunosuppressive, or immune modulator therapies in the last 3 months. It also excludes those using inhaled nasal sprays.
What data supports the effectiveness of the drug Dupilumab for asthma?
Dupilumab has shown effectiveness in treating severe type-2 asthma by targeting specific pathways involved in inflammation, and its efficacy has been demonstrated in clinical trials. It is already used for other conditions like atopic dermatitis and chronic rhinitis, indicating its potential in managing asthma symptoms.12345
Is dupilumab safe for treating asthma?
Dupilumab is generally considered safe for treating asthma, with studies showing minimal adverse events compared to a placebo. However, it may cause an increase in blood eosinophils (a type of white blood cell) and has been associated with some ocular (eye-related) adverse events, mostly in patients treated for atopic dermatitis.12678
What makes the drug Dupilumab unique for treating asthma?
Dupilumab is unique because it targets the IL-4 and IL-13 signaling pathways, which are involved in the inflammation process of asthma. This mechanism may offer an advantage over other biologics by being effective in both eosinophilic and non-eosinophilic severe asthma types, unlike some existing treatments.12347
Research Team
Larry Borish, MD
Principal Investigator
University of Virginia
Eligibility Criteria
Adults aged 18-40 with mild, well-controlled asthma may join this study. They must have a positive methacholine test, certain blood or breath markers of inflammation, and no recent use of strong immune therapies. Smokers or those with other lung diseases can't participate. Women who can get pregnant must use effective birth control.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either dupilumab or placebo and are subsequently exposed to the rhinovirus
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in biomarkers and symptoms
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Dupilumab (Monoclonal Antibodies)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor