Examining the effects of dupilumab on asthma symptoms after a cold virus exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether dupilumab, a medication approved for moderate to severe asthma, can help prevent worsening asthma symptoms in individuals with mild persistent asthma after exposure to a common cold virus (rhinovirus). The trial involves 60 adult participants aged 18-40 who will be randomly assigned to receive either dupilumab or a placebo. Participants will undergo a controlled exposure to the rhinovirus, and the study aims to understand the cellular and molecular mechanisms by which dupilumab may mitigate asthma exacerbations caused by viral infections. The double-blind design ensures unbiased results.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Larry Borish, MD — University of Virginia
• Study coordinator: Kristin W Wavell Shifflett, BS, CCRC
• Email: kwavell@gmail.com
• Phone: 4349817599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.