Status:
RECRUITING
Viral Infection in Asthma (VIA) Study
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
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 stu...
Detailed Description
Rhinovirus (RV) is responsible for up to 70-80% of asthmatic exacerbations in children and adolescents requiring urgent care or hospitalizations. Understanding the mechanism by which this otherwise re...
Eligibility Criteria
Inclusion
- 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
- 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
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- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04380038
Start Date
May 1 2022
End Date
December 31 2026
Last Update
April 1 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908