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Trial record 13 of 762 for:    Tobacco Smoke

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
Sponsor:
Collaborators:
Environmental Protection Agency (EPA)
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. IL-13 [ Time Frame: 1-21 days ]
    Change in IL-13 and ECP in nasal lavage fluids (NLF) compared to pre-virus baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Oxygen saturation of > 94%
  3. Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
  4. Symptom Score no greater than 6 (out of a possible 39) for total symptom score
  5. On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally

Exclusion Criteria:

  1. 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)
  2. Positive pregnancy test within 48 hours of the time of challenge
  3. 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.
  4. Receipt of LAIV in the current season
  5. History of allergy to eggs
  6. 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
  7. Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.
  8. Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
center for envionmental medicine asthma an lung biology at the EPA
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Environmental Protection Agency (EPA)
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Terry Noah, MD University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02183753     History of Changes
Other Study ID Numbers: 13-3076
5R01ES013611-09 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by University of North Carolina, Chapel Hill:
LAIV
Flumist
wood smoke

Additional relevant MeSH terms:
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Inflammation
Virus Diseases
Pathologic Processes