Viral Infection in Asthma (VIA) Study

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: Regeneron Pharmaceuticals

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 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. IgE≥150kU/L

9. Negative (≤1:4) serum neutralizing HRV antibody to HRV 16.

10. Willing and able to comply with clinic visits and study-related procedures

11. Provide informed consent signed by study patient

12. 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

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.