RECRUITING

Viral Mucosal Reprogramming

Conditions

Asthma Allergic Rhinitis Cat Allergy Healthy Allergy Allergic Rhinitis Airway Cat dander Respiratory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-27

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05331170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject must be able to understand and provide informed consent 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of asthma, COPD, rhinitis, or other clinically important respiratory disease 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote. 6. No history of diabetes or cardiovascular disease 7. Negative ImmunoCAP test to regionally relevant allergen panel obtained at Screening. Alternatively, documented history of a negative skin test or negative specific IgE obtained within the past 12 months. 1. Subject must be able to understand and provide informed consent 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of asthma, COPD, or other clinically important respiratory disease 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote 6. No history of diabetes or cardiovascular disease 7. History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months 8. Seasonal or perennial nasal congestion or sneezing 9. Seasonal or perennial conjunctival infection or watering 10. No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal) 11. Positive ImmunoCAP test to cat. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criterion. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months. 1. Subject must be able to understand and provide informed consent 2. Age: 18-60 inclusive 3. Sex: M or F 4. No history of COPD or other clinically important respiratory disease other than asthma 5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote 6. No history of diabetes or cardiovascular disease 7. History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months 1. Airway obstruction (FEV1: FVC \<0.6) that is significantly (at least 12% change from baseline, ATS criteria) reversible after 4 puffs of albuterol (obtained at Screening Visit or documented historical testing performed with the past 12 months) 2. Requiring ICS for control of asthma for at least 30 days within the past 12 months 8. Positive ImmunoCAP test to cat dander. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criteria. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months. 9. Results of the CBC do not show clinically important abnormalities	1. Inability or unwillingness of a participant to comply with study protocol 2. Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease. 3. Neutralizing Ab to RV16 greater than or equal to 1:8 4. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at the screening visit. Pregnancy testing may be conducted prior to procedures as well at various times in the study. 5. Subjects with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV). 6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver). 1. Inability or unwillingness of a participant to comply with study protocol 2. Currently using inhaled steroids, or oral montelukast for respiratory disease 3. Neutralizing Ab to RV16 greater than or equal to 1:8 4. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening visit. Pregnancy testing may be conducted prior to procedures as well at various times in the study. 5. Subjects with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV) . 6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver). 7. Subjects who have received immunosuppressive treatment within the last 12 months 8. BMI is greater than 35 9. History of symptoms consistent with a viral URI within the past 21 days 10. Results of the CBC do not show clinically important abnormalities 11. Family history or medical history of liver disease or bleeding disorders 12. Have not received systemic corticosteroids for 3months prior to Screening 13. Antiplatelet agents other than aspirin 14. Subjects who have a positive COVID-19 test will be excluded for 8 weeks 1. Inability or unwillingness of a participant to comply with study protocol 2. Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs. 3. Neutralizing Ab to RV16 greater than or equal to 1:8 4. FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted 5. Recent (\<30 days) exacerbation of asthma requiring systemic corticosteroids 6. ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening. 7. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening. Pregnancy testing may be conducted prior to procedures as well at various times in the study. 8. Subjects with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV) . 9. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver). 10. Subjects who have received immunosuppressive treatment within the last 12 months 11. BMI is greater than 35 12. History of symptoms consistent with a viral URI within the past 21 days 13. Family history or medical history of liver disease or bleeding disorders 14. Have not received systemic corticosteroids for 3 months prior to Screening 15. Have an ACT score \>19 at the time of enrollment. 16. Antiplatelet agents other than aspirin 17. Subjects who have a positive COVID-19 test will be excluded for 8 weeks

Inclusion Criteria

Exclusion Criteria

1. Subject must be able to understand and provide informed consent
2. Age: 18-60 inclusive
3. Sex: M or F
4. No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote.
6. No history of diabetes or cardiovascular disease
7. Negative ImmunoCAP test to regionally relevant allergen panel obtained at Screening. Alternatively, documented history of a negative skin test or negative specific IgE obtained within the past 12 months.
1. Subject must be able to understand and provide informed consent
2. Age: 18-60 inclusive
3. Sex: M or F
4. No history of asthma, COPD, or other clinically important respiratory disease
5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
6. No history of diabetes or cardiovascular disease
7. History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months
8. Seasonal or perennial nasal congestion or sneezing
9. Seasonal or perennial conjunctival infection or watering
10. No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal)
11. Positive ImmunoCAP test to cat. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criterion. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months.
1. Subject must be able to understand and provide informed consent
2. Age: 18-60 inclusive
3. Sex: M or F
4. No history of COPD or other clinically important respiratory disease other than asthma
5. Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
6. No history of diabetes or cardiovascular disease
7. History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months
1. Airway obstruction (FEV1: FVC \<0.6) that is significantly (at least 12% change from baseline, ATS criteria) reversible after 4 puffs of albuterol (obtained at Screening Visit or documented historical testing performed with the past 12 months)
2. Requiring ICS for control of asthma for at least 30 days within the past 12 months
8. Positive ImmunoCAP test to cat dander. Documented history at any time of a positive skin test or a specific IgE measure at least Level 2 reactivity will meet this criteria. Subjects must have cat in home, have regular exposure to cat dander, or live in a home where a cat has lived within the past 6 months.
9. Results of the CBC do not show clinically important abnormalities

1. Inability or unwillingness of a participant to comply with study protocol
2. Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease.
3. Neutralizing Ab to RV16 greater than or equal to 1:8
4. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at the screening visit. Pregnancy testing may be conducted prior to procedures as well at various times in the study.
5. Subjects with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV).
6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
1. Inability or unwillingness of a participant to comply with study protocol
2. Currently using inhaled steroids, or oral montelukast for respiratory disease
3. Neutralizing Ab to RV16 greater than or equal to 1:8
4. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening visit. Pregnancy testing may be conducted prior to procedures as well at various times in the study.
5. Subjects with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV) .
6. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
7. Subjects who have received immunosuppressive treatment within the last 12 months
8. BMI is greater than 35
9. History of symptoms consistent with a viral URI within the past 21 days
10. Results of the CBC do not show clinically important abnormalities
11. Family history or medical history of liver disease or bleeding disorders
12. Have not received systemic corticosteroids for 3months prior to Screening
13. Antiplatelet agents other than aspirin
14. Subjects who have a positive COVID-19 test will be excluded for 8 weeks
1. Inability or unwillingness of a participant to comply with study protocol
2. Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs.
3. Neutralizing Ab to RV16 greater than or equal to 1:8
4. FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted
5. Recent (\<30 days) exacerbation of asthma requiring systemic corticosteroids
6. ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening.
7. Pregnant or breastfeeding women or a woman who has a planned pregnancy during the course of the study. Menstruating females must have a negative pregnancy test at screening. Pregnancy testing may be conducted prior to procedures as well at various times in the study.
8. Subjects with household or close contacts who are pregnant or planning a pregnancy during the main subject's participation, who have chronic respiratory disease, who are children under the age of 2 years, or who are adults over 60 years of age or are Immunosuppressed e.g. post-chemotherapy, HIV) .
9. Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
10. Subjects who have received immunosuppressive treatment within the last 12 months
11. BMI is greater than 35
12. History of symptoms consistent with a viral URI within the past 21 days
13. Family history or medical history of liver disease or bleeding disorders
14. Have not received systemic corticosteroids for 3 months prior to Screening
15. Have an ACT score \>19 at the time of enrollment.
16. Antiplatelet agents other than aspirin
17. Subjects who have a positive COVID-19 test will be excluded for 8 weeks

Contacts and Locations

Study Contact

Lisa Sweeney, RN

CONTACT

409-747-5871

lanemeth@utmb.edu

Principal Investigator

William J. Calhoun, MD

PRINCIPAL_INVESTIGATOR

University of Texas

Study Locations (Sites)

University of Texas Medical Branch

Galveston, Texas, 77555

United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

William J. Calhoun, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-27

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2023-04-27

Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

Asthma
Allergy
Allergic
Rhinitis
Airway
Cat dander
Respiratory

Additional Relevant MeSH Terms

Asthma
Allergic Rhinitis
Cat Allergy
Healthy