Treatment for Rhinitis, Allergic

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Virginia Health System, Charlottesville, VA
Rhinitis, Allergic+3 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Rhinitis, Allergic

Study Summary

This study is evaluating whether a nasal inoculation of a virus can cause asthma in people with asthma.

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Eligible Conditions

  • Rhinitis, Allergic
  • Rhinitis
  • Asthma
  • Allergic Rhinitis (Disorder)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Rhinitis, Allergic. Measurement will happen over the course of Change in symptom score from day 0 to day 4 after inoculation with the rhinovirus.

Day 4
Change in symptom scores induced by the rhinovirus using Jackson criteria including nasal congestion, drainage, cough, wheezing

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

Healthy control

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Healthy control
Biological
Healthy controls will be infected with Rhinovirus (GMP RV16 HRV-16)
Allergic rhinitis
Biological
Allergic rhinitis subjects will be infected with Rhinovirus (GMP RV16 HRV-16)
Asthmatic
Biological
Asthmatic subjects will be infected with Rhinovirus (GMP RV16 human (H)RV-16)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in symptom score from day 0 to day 4 after inoculation with the rhinovirus
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change in symptom score from day 0 to day 4 after inoculation with the rhinovirus for reporting.

Who is running the study

Principal Investigator
L. B.
Prof. Larry Borish, MD
University of Virginia

Closest Location

University of Virginia Health System - Charlottesville, VA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects must be able to understand and provide written informed consent.
Age 18 to ≤40 years of age, any gender, any racial/ethnic origin
Female subjects of childbearing potential must have a negative pregnancy test upon study entry (day -7) and before each procedure involving pharmacologic interventions (days 0, 4, and 7).
Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, abstinence, or condoms.
Participants must be willing to comply with study procedures and requirements.
Negative test for serum neutralizing antibody to RV16 at enrollment visit (<1:8) (Visit 1).
Allergy as determined by ≥1 positive prick skin test (wheal ≥5 mm diameter and 3mm larger than the diluent control) to Virginia inhalant panel within 5 years, and a history of symptoms of sneezing, rhinorrhea, pruritus, nasal congestion, and/or allergic conjunctivitis on natural exposure to relevant allergens.
Negative methacholine challenge (less than 20% decline in functional expiratory volume in 1 second (FEV1) at ≤8mg/ml) within 1 year
FEV1 ≥80% predicted, FEV1/FVC ≥80%.
No history of wheezing with viral infection in the last 6 years, and no use of rescue inhalers or long-term controllers for asthma in the last 6 years.

Patient Q&A Section

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Other questions from users

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Rhinitis, Allergic by sharing your contact details with the study coordinator.