SuspendedNot Applicable

To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility

Stopped: We no longer have access to the Wood smoke chamber and will need to rework how we do the wood smoke exposures.

United States160 participantsStarted 2016-05

Plain-language summary

Purpose: This screening protocol is designed to assess PMN (neutrophil) responsiveness to wood smoke particles (WSP) and the effect of the GSTM1 null genotype on this response. The researches will identify persons responsive and resistant to the inflammatory effect of WSP. It is anticipated that the GSTM1 genotype will be a risk factor for increased response to WSP.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-45 of both genders
. Negative pregnancy test for females who are not s/p hysterectomy with oopherectomy
. Calculated 10 year risk of CVD by the Framingham risk score of \<5%
. Proof of Covid vaccination

Exclusion criteria

. Clinical contraindications:
. Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in % neutrophils in induced sputum, comparing the 4 hr post wood smoke exposure to the baseline

Timeframe: baseline, and 4 hours post exposure

Change from baseline in post wood smoke airway neutrophil influx between GSTM1 null genotype compared to GSTM1 sufficient subjects

Timeframe: baseline, and 4 hours post exposure

Trial details

NCT IDNCT02767973

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Airway Inflammation trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-45 of both genders
. Negative pregnancy test for females who are not s/p hysterectomy with oopherectomy
. Calculated 10 year risk of CVD by the Framingham risk score of \<5%
. Proof of Covid vaccination

Exclusion criteria

. Clinical contraindications:
. Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis.

What they're measuring

Change in % neutrophils in induced sputum, comparing the 4 hr post wood smoke exposure to the baseline

Timeframe: baseline, and 4 hours post exposure

Change from baseline in post wood smoke airway neutrophil influx between GSTM1 null genotype compared to GSTM1 sufficient subjects

Timeframe: baseline, and 4 hours post exposure