NCT04380038 · University of Virginia
Viral Infection in Asthma (VIA) Study
(VIA)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Dupilumab Injectable Product
Nasal inoculation, single dose 300 TCID50 in 1ml.
Primary outcome measures
Change in interleukin-25 transcript expression post-rhinovirus inoculation
Time frame: Day 0 to day 4 post-inoculation with the rhinovirus
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
- bilateral tubal ligation
- vasectomized partner and/or <!-- -->
- 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.
Where
- Charlottesville, Virginia
Collaborators
Regeneron Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2025 · Source of record for eligibility and locations