Viral Infection in Asthma (VIA) Study

NCT04380038 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HSR200039
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in interleukin-25 transcript expression post-rhinovirus inoculation

  Comparison of the change in IL-25 transcript expression in nasal scraping samples as determined by semi-quantitative polymerase chain reaction between the placebo- and dupilumab-treated cohorts

  Day 0 to day 4 post-inoculation with the rhinovirus

Secondary Outcomes (4)

• Change in transcriptome in nasal brushing samples post-rhinovirus inoculation

  Day 0 to day 14 post-inoculation with the rhinovirus

• Change in the proteome in nasal wash samples post-rhinovirus inoculation

  Day 0 to day 14 post-inoculation with the rhinovirus

• Change in allergen-specific Th2 effector lymphocytes post-rhinovirus inoculation

  Day 0 to day 14

• Change in symptoms post-rhinovirus inoculation

  Day 0 to day 14

Study Arms (2)

Dupilumab

ACTIVE COMPARATOR

The dupilumab dose regimen selected for this study (300 mg q2w after an initial loading dose of 600 mg)

Drug: Dupilumab Injectable Product

Placebo

PLACEBO COMPARATOR

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.

Drug: Dupilumab Injectable Product

Interventions

Dupilumab Injectable Product DRUG

Nasal inoculation, single dose 300 TCID50 in 1ml.

Also known as: Rhinovirus

Dupilumab; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult ages 18-40
• Physician diagnosed asthma for at least 6 months
• Mild persistent asthma well controlled (ACT≥20) over 6-month period prior to enrollment
• FEV1 of \>80% predicted
• 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.
• Positive methacholine test (≤16 mg/ml)
• Blood eosinophil count ≥150/µL or FeNO ≥20 ppb
• Negative (≤1:4) serum neutralizing HRV antibody to HRV 16 or HRV 39.
• Willing and able to comply with clinic visits and study-related procedures
• Provide informed consent signed by study patient
• Able to understand and complete study-related questionnaires

You may not qualify if:

• Current smoker or has smoked regularly for 10 yrs and smoked \>10 pack-years
• History or clinical evidence of COPD or any other significant lung disease
• Known allergy to any ingredients in the study drug product
• Asthma biologic therapy in last 3 months (including dupilumab)
• 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
• Any history of an asthma exacerbation requiring Emergency Department visit, intubation or hospitalization
• History of asthma exacerbation requiring unscheduled office visit or oral corticosteroids within the past 3 years
• Members of the clinical site study team and/or his/her immediate family
• Pregnant or breastfeeding women
• 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:
• 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
• intrauterine device (IUD); intrauterine hormone releasing system (IUS)

Sponsors & Collaborators

• University of Virginia: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Larry Borish, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin W Wavell Shifflett, BS, CCRC

CONTACT

4349817599; kwavell@gmail.com

Deborah Murphy, RN

CONTACT

(434) 982-3510; DDM9Q@hscmail.mcc.virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo group provides a reference for the interpretation of study results, so the net effect of dupilumab could be discerned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Professor of Medicine and Microbiology Asthma and Allergic Disease Center

Model Details: Double-blind, Randomized study design.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 8, 2020
• Study Start: May 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)