Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT04380038

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Dupilumab Injectable Product

Study Details

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

Study ID

NCT04380038

Start date

May 1, 2022

Status verified date

Mar, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult ages 18-40
2. Physician diagnosed asthma for at least 6 months
3. Mild persistent asthma well controlled (ACT≥20) over 6-month period prior to enrollment
4. FEV1 of >80% predicted
5. 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.
6. Positive methacholine test (≤16 mg/ml)
7. Blood eosinophil count ≥150/µL or FeNO ≥20 ppb
8. Negative (≤1:4) serum neutralizing HRV antibody to HRV 16 or HRV 39.
9. Willing and able to comply with clinic visits and study-related procedures
10. Provide informed consent signed by study patient
11. Able to understand and complete study-related questionnaires

Exclusion Criteria:

1. Current smoker or has smoked regularly for 10 yrs and smoked >10 pack-years
2. History or clinical evidence of COPD or any other significant lung disease
3. Known allergy to any ingredients in the study drug product
4. Asthma biologic therapy in last 3 months (including dupilumab)
5. Antiviral, immunosuppressive, or immune modulator therapies in the last 3 months
6. Use of any inhaled nasal sprays
7. Upper or lower respiratory tract infection in the last 6 weeks
8. Asthma exacerbation in the last 6 weeks
9. Any history of an asthma exacerbation requiring Emergency Department visit, intubation or hospitalization
10. History of asthma exacerbation requiring unscheduled office visit or oral corticosteroids within the past 3 years
11. Members of the clinical site study team and/or his/her immediate family
12. Pregnant or breastfeeding women
13. 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:

1. 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
2. intrauterine device (IUD); intrauterine hormone releasing system (IUS)
3. bilateral tubal ligation
4. vasectomized partner and/or

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1. 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dupilumab

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

placebo comparator: Placebo

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.

Interventions

Dupilumab Injectable Product

Nasal inoculation, single dose 300 TCID50 in 1ml.

Primary outcome measure

  • Change in interleukin-25 transcript expression post-rhinovirus inoculation [ Time Frame: Day 0 to day 4 post-inoculation with the rhinovirus ]

Central Contacts and Locations

Central contacts

Kristin W Wavell Shifflett, BS, CCRC

4349817599kwavell@gmail.com

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Larry Borish, MD

More Information

Sponsor

University of Virginia

Last update posted

Apr 1, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-04-01.