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Status:

RECRUITING

Viral Mucosal Reprogramming

Lead Sponsor:

The University of Texas Medical Branch, Galveston

Collaborating Sponsors:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Asthma

Allergic Rhinitis

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief 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 ...

Eligibility Criteria

Inclusion

  • Healthy Normal Control Group
  • Subject must be able to understand and provide informed consent
  • Age: 18-60 inclusive
  • Sex: M or F
  • No history of asthma, COPD, rhinitis, or other clinically important respiratory disease
  • Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote.
  • No history of diabetes or cardiovascular disease
  • 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.
  • Allergic Rhinitis Group
  • Subject must be able to understand and provide informed consent
  • Age: 18-60 inclusive
  • Sex: M or F
  • No history of asthma, COPD, or other clinically important respiratory disease
  • Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
  • No history of diabetes or cardiovascular disease
  • History of rhinitis, physician diagnosed, plus one of the following criteria within the past 12 months
  • Seasonal or perennial nasal congestion or sneezing
  • Seasonal or perennial conjunctival infection or watering
  • No evidence of airway obstruction (FEV1:FVC ≥ lower limit of normal)
  • 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.
  • Allergic Asthma Group
  • Inclusion Criteria
  • Subject must be able to understand and provide informed consent
  • Age: 18-60 inclusive
  • Sex: M or F
  • No history of COPD or other clinically important respiratory disease other than asthma
  • Non-smoker, or ex-smoker with \<10 pack years, at least 5 years remote
  • No history of diabetes or cardiovascular disease
  • History of mild-moderate asthma, physician diagnosed, plus one of the following criteria within the past 12 months
  • 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)
  • Requiring ICS for control of asthma for at least 30 days within the past 12 months
  • 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.
  • Results of the CBC do not show clinically important abnormalities

Exclusion

  • Healthy Group Normal Group
  • Inability or unwillingness of a participant to comply with study protocol
  • Currently taking inhaled corticosteroids, leukotriene modifier, or antihistamines for respiratory disease.
  • Neutralizing Ab to RV16 greater than or equal to 1:8
  • 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.
  • 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).
  • Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
  • Allergic Rhinitis Group
  • Inability or unwillingness of a participant to comply with study protocol
  • Currently using inhaled steroids, or oral montelukast for respiratory disease
  • Neutralizing Ab to RV16 greater than or equal to 1:8
  • 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.
  • 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) .
  • Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
  • Subjects who have received immunosuppressive treatment within the last 12 months
  • BMI is greater than 35
  • History of symptoms consistent with a viral URI within the past 21 days
  • Results of the CBC do not show clinically important abnormalities
  • Family history or medical history of liver disease or bleeding disorders
  • Have not received systemic corticosteroids for 3months prior to Screening
  • Antiplatelet agents other than aspirin
  • Subjects who have a positive COVID-19 test will be excluded for 8 weeks
  • Allergic Asthma Group
  • Inability or unwillingness of a participant to comply with study protocol
  • Currently taking medications for respiratory diseases other than ICS, montelukast, or rescue albuterol or LABAs.
  • Neutralizing Ab to RV16 greater than or equal to 1:8
  • FEV1: FVC ratio less than 0.6, or FEV1 less than 60% predicted
  • Recent (\<30 days) exacerbation of asthma requiring systemic corticosteroids
  • ICS greater than fluticasone 500 mcg/day or its equivalent (GINA 2019 table) at screening.
  • 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.
  • 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) .
  • Subjects who provide healthcare services or work with elderly or children (e.g. daycare provider, senior citizen care giver).
  • Subjects who have received immunosuppressive treatment within the last 12 months
  • BMI is greater than 35
  • History of symptoms consistent with a viral URI within the past 21 days
  • Family history or medical history of liver disease or bleeding disorders
  • Have not received systemic corticosteroids for 3 months prior to Screening
  • Have an ACT score \>19 at the time of enrollment.
  • Antiplatelet agents other than aspirin
  • Subjects who have a positive COVID-19 test will be excluded for 8 weeks

Key Trial Info

Start Date :

April 27 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2027

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT05331170

Start Date

April 27 2023

End Date

May 1 2027

Last Update

January 28 2025

Active Locations (1)

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1

University of Texas Medical Branch

Galveston, Texas, United States, 77555