RecruitingPhase 2NCT05331170

Viral Mucosal Reprogramming

Epigenetic Mechanism Reprogramming Mucosal Anti-viral Immunity in Allergic Asthma VIRAL MUCOSAL REPROGRAMMING

Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

75 participants

Start Date

Apr 27, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma Healthy Allergic Rhinitis Cat Allergy

Summary

This is a mechanistic, controlled, open-label, single-site study to evaluate the effects of RG-RV16 inoculation on airway mucosal gene expression and airway remodeling in 25 healthy controls (HC), in 25 allergic rhinitis subjects (AR) with cat dander allergy, and in 25 allergic asthmatic subjects (AA) with cat dander allergy. Three groups (HC, AR, and AA) will undergo screening to establish clinical history, will undergo pulmonary function testing (spirometry), and will have blood drawn for clinical characterization (IgE, , ImmunoCAP, CBC and differential), and for assessing the presence of existing neutralizing antibody against RV16. Only those who meet criteria will be permitted to continue into the interventional and run-out phases of the study.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how the airways respond to a controlled rhinovirus infection (common cold virus) in three groups: healthy people, people with allergic rhinitis (hay fever), and people with allergic asthma, to better understand how viruses trigger respiratory symptoms. **You may be eligible if...** - You are 18–60 years old - You are a non-smoker (or quit more than 5 years ago with minimal smoking history) - You fit one of these profiles: healthy with no respiratory disease, OR diagnosed with allergic rhinitis with cat allergy, OR diagnosed with mild-to-moderate allergic asthma with cat allergy **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have household contacts who are pregnant, immunosuppressed, under 2 years old, or over 60 - You work with elderly people or young children - You have had recent cold-like symptoms in the past 21 days - You have a BMI over 35 - You recently tested positive for COVID-19 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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