Healthy Volunteers Clinical Trial
Official title:
Study of Airway Inflammatory Responses to Experimental Rhinovirus Infection
NCT number | NCT03508479 |
Other study ID # | 16-3283 |
Secondary ID | |
Status | Suspended |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | July 2026 |
Verified date | August 2023 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 23 |
Est. completion date | July 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Age 18-45 years of either gender 2. Non-smoker (less than 10 cigarettes per month for at least the prior 3 years) 3. Negative pregnancy test (for females as applicable) 4. Oxygen saturation of > 94% and blood pressure with systolic value between 140-90 mm Hg and diastolic between 80-55 mm Hg 5. 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. 6. 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.) 7. 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). 8. Normal lung function, defined as (NHANES III predicted set): - Forced Vital Capacity (FVC) of = 80 % of that predicted for gender, ethnicity, age and height - FEV1 of = 80 % of that predicted for gender, ethnicity, age and height - Ratio of Forced Exhaled Volume at 1 second to Forced Vital Capacity (FEV1/FVC) = .75 9. No nasal symptoms, based on respiratory questionnaire Exclusion Criteria: 1. Presence of neutralizing antibodies to RG-HRV-16 at the screening visit to a titer of = 1:2. 2. Inability or unwillingness of a participant to give written informed consent 3. History of rhinitis, chronic sinusitis, or other sinus disease, or any chronic cardiorespiratory disease 4. 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 5. Subjects who live in communal settings (i.e. dormitories) 6. Respiratory infection (cough, sore throat, sinusitis, fever etc) within prior 4 weeks 7. Received any live vaccine in the past 4 weeks or an inactivated vaccine within the past 2 weeks 8. Active wheezing at the time of the Day 0 visit 9. Pregnancy or nursing or women who are currently trying to become pregnant; all female subjects, except those who have had a hysterectomy with oophorectomy, will undergo urine pregnancy testing on the morning of the screening visit and again on the on Day 0 at the time of arrival to the lab and prior to HRV administration. A positive pregnancy test will exclude the subject 10. History of any immunosuppressive disease or a positive Human immunodeficiency virus (HIV) test at the screening visit 11. Use of immunosuppressive drugs within the past 6 months 12. Chronic medications which, in the opinion of the study physician(s), may either increase the risks of participation or may interfere with the findings of the study 13. Current use of beta-adrenergic blocking agents 14. Current use of antidepressants if classified as tricyclic or Monoamine oxidase inhibitors (MAO) inhibitors; 15. Known hypersensitivity to methacholine or to other parasympathomimetic agents; 16. History of fainting or feeling severely dizzy with blood draws 17. History of Guillain-Barre syndrome 18. Subjects who will be unable to avoid contact with immunocompromised individuals for 3 weeks after receiving RG-HRV16 19. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study; 20. Unwillingness to use reliable contraception if sexually active (Intrauterine Device (IUD), birth control pills/patch, condoms) 21. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements 22. Participation in any study using an investigational agent within 30 days of enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | UNC Center for Environmental Medicine, Asthma and Lung Biology | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in neutrophils/mL in nasal lavage fluid from baseline to mean of days 2-4 post inoculation | Nasal lavage fluid will be collected at baseline. Participants will then undergo RG-HRV16 inoculation. Nasal lavage fluid will be collected on days 2-3 post inoculation and mean neutrophils/ml over days 2-4 will be compared to baseline. | Baseline and study visit days 2-4 | |
Secondary | Mean Symptom Score from Cold Symptom Questionnaire up to 4 weeks post-inoculation | Assessment of eight clinical symptoms on the day of RG-HRV16 inoculation and days 2, 3, 4, 7, 14, 28 following inoculation will be performed with a cold symptom questionnaire. Scores of 0, 1, 2, or 3 will be given to symptoms rated as absent, mild, moderate, or severe, respectively. Minimum score: 0. Maximum score: 32. | 4 weeks post-inoculation | |
Secondary | Change in FEV1 and FEF25-75% from baseline to 4 weeks post-inoculation | Changes in FEV1 and FEF25-75% (mean forced expiratory flow between 25% and 75% of the FVC or maximum mid-expiratory flow) from baseline will be assessed up to 4 weeks post-RG-HRV16 inoculation (on days 2, 3, 4, 7, 14, and 28 following inoculation). | Baseline and 4 weeks post-inoculation | |
Secondary | Change in Methacholine reactivity, as measured by the concentration of methacholine resulting in a 20% drop in FEV1 (PC20), from baseline to day 4 post-inoculation | Participants will undergo a methacholine challenge to assess airway hyper-responsiveness at baseline. Changes in methacholine reactivity, as measured by the PC20, from baseline to 4 days after RG-HRV16 inoculation will be determined. | Baseline and study visit day 4 (post-inoculation) |
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