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