Study of Airway Inflammatory Responses to Experimental Rhinovirus Infection (NCT03508479) | Clinical Trial Compass
WithdrawnPhase 1
Study of Airway Inflammatory Responses to Experimental Rhinovirus Infection
Stopped: Suspended due to COVID-19. Protocol did not resume post COVID due to funding.
United States0Started 2024-12
Plain-language summary
This study is designed to characterize in detail the clinical, physiologic, and inflammatory features of Human Rhinovirus (HRV) infection in healthy volunteers without underlying lung disease while also evaluating the safety of HRV administrations.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Age 18-45 years of either gender
✓. Non-smoker (less than 10 cigarettes per month for at least the prior 3 years)
✓. Negative pregnancy test (for females as applicable)
✓. Oxygen saturation of \> 94% and blood pressure with systolic value between 140-90 mm Hg and diastolic between 80-55 mm Hg
✓. Willingness to hold all nasal medications (including, but not limited to, nasal steroids or nasal spray decongestants), oral antihistamines and leukotriene inhibitors for at least 1 week prior to Day 0 and continuing throughout the remaining study period.
✓. Negative Allergy Skin Test (AST) at a separate screening visit performed prior to study enrollment, University of North Carolina Institutional Review Board (UNC IRB) approved study # 98-0799, Database and Screening Protocol for Research Studies of the Center for Environmental Medicine and Lung Biology (CEMALB). (Results from AST performed within the past 12 months as part of another study protocol or AST reports from testing performed by the subject's Medical Doctor (MD) within the past 12 months will also be accepted.)
✓. Negative methacholine inhalation challenge as performed in the separate screening protocol. (Less than a 20% decrease in Forced Exhaled Volume at 1 second (FEV1) at a maximum methacholine concentration of 10 mg/ml).
✓. Normal lung function, defined as (NHANES III predicted set):
Exclusion criteria
✕. Presence of neutralizing antibodies to RG-HRV-16 at the screening visit to a titer of ≥ 1:2.
What they're measuring
1
Change in neutrophils/mL in nasal lavage fluid from baseline to mean of days 2-4 post inoculation
✕. Inability or unwillingness of a participant to give written informed consent
✕. History of rhinitis, chronic sinusitis, or other sinus disease, or any chronic cardiorespiratory disease
✕. Subjects with household contacts with chronic lung disease, who are children under the age of 2 years, and who are adults over the age of 65 years
✕. Subjects who live in communal settings (i.e. dormitories)