Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 40
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Virginia · Other
Who this trial is looking for
This trial is looking for adults with mild to moderate asthma to see if the medication dupilumab can help prevent worsening asthma symptoms after getting a cold virus. Participants will receive either dupilumab or a placebo and be exposed to a common cold virus.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 to 40 years old.
I have been diagnosed with asthma for at least 6 months.
I have mild persistent asthma that is well controlled.
I have good lung function (FEV1 >80% predicted).
I only use albuterol or low to medium dose inhaled corticosteroids for my asthma.
I have a positive methacholine test result.
I have a blood eosinophil count of at least 150/µL.
I am willing and able to attend clinic visits.
You may not be able to join if
I am a current smoker or have a history of heavy smoking.
I have a history of COPD or significant lung disease.
I am allergic to any ingredients in the study medication.
I have received asthma biologic therapy in the last 3 months.
I have taken antiviral or immunosuppressive therapies in the last 3 months.
I have had a respiratory tract infection in the last 6 weeks.
I have had an asthma exacerbation in the last 6 weeks.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 dup…
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.
Trial Locations
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Eligibility Criteria
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…
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.
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