Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers (Woodsies)
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|ClinicalTrials.gov Identifier: NCT02183753|
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : June 11, 2015
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 to wood smoke particles (WSP) enhances influenza virus-induced granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production. Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project, the purpose of the study is also to test novel assays of granulocyte activation (Doershuk lab) and lipid mediator activation (Albritton lab) which have not previously been used in this type of research.
Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo controlled study comparing NLF granulocyte responses to LAIV administered after either WSP or clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean air), followed by a standardized dose of LAIV and serial post-infection sampling of nasal lavage fluids, nasal biopsy and blood
|Condition or disease||Intervention/treatment||Phase|
|Response of Viral Infection to Woodsmoke||Other: wood smoke Other: clean air||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||April 2015|
Active Comparator: Wood smoke
The dose of WSP to be used (500 µg/m3 for 2 hours) is based on prior studies which indicate the exposure is well tolerated, and is similar to that found in some indoor exposures in homes heated by wood burning (24-26). The route of administration (breathing air containing WSP at rest, nasally) is intended to mimic natural exposures.
Other: wood smoke
Placebo Comparator: clean air
Chapel Hill air which has been filtered to remove ambient air pollutants.
Other: clean air
- IL-13 [ Time Frame: 1-21 days ]Change in IL-13 and ECP in nasal lavage fluids (NLF) compared to pre-virus baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183753
|United States, North Carolina|
|center for envionmental medicine asthma an lung biology at the EPA|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Terry Noah, MD||University of North Carolina, Chapel Hill|