Status:
COMPLETED
Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Environmental Protection Agency (EPA)
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Response of Viral Infection to Woodsmoke
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief Summary
This study is focused on the pathophysiology underlying the association between exposure to particulate pollutants and risk for/response to viral infection. The investigators hypothesize that exposure...
Eligibility Criteria
Inclusion
- Normal lung function, defined as (Knudson 1976/1984 predicted set): FVC \> 75 % predicted for gender, ethnicity, age and height; FEV1 \>75 % predicted ; FEV1/FVC ratio \>0.70 and \< 0.90.
- Oxygen saturation of \> 94%
- Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
- Symptom Score no greater than 6 (out of a possible 39) for total symptom score
- On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally
Exclusion
- A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
- Positive pregnancy test within 48 hours of the time of challenge
- Use of any inhaled substance (for medical or recreational purposes). Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year and does not smoke at all 1 week prior to entrance in the study.
- Receipt of LAIV in the current season
- History of allergy to eggs
- Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks
- Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.
- Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02183753
Start Date
July 1 2014
End Date
April 1 2015
Last Update
June 11 2015
Active Locations (1)
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1
center for envionmental medicine asthma an lung biology at the EPA
Chapel Hill, North Carolina, United States, 27599