Asthma study: Dupilumab Injectable Product
Official title Viral Infection in Asthma (VIA) Study
ClinicalTrials.gov ID: NCT04380038
What this study is testing
What is Dupilumab Injectable Product?
An investigational injectable medicine being studied to see if it can prevent worsening of asthma symptoms after exposure to a rhinovirus. It is designed to block IL-4 and IL-13 signaling pathways that contribute to allergic inflammation in the lungs.
Also referred to as Dupilumab.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether dupilumab can prevent worsening asthma symptoms after a cold virus in people with mild to moderate asthma.
- Who it's for
- You may be able to join if you have mild to moderate asthma and are otherwise healthy.
- What's involved
- You will receive either dupilumab (a medicine that blocks asthma inflammation) or a pretend treatment, then be given a safe cold virus. You will have lung tests, questionnaires, and sample collections.
- Time commitment
- The study lasts several weeks with several clinic visits for the virus exposure and follow‑up checks.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join 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...
You likely can't join 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
See the full eligibility 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...
- 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
- 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
- stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Charlottesville, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.