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Genetic Screening for Inflammation Response to Wood Smoke Particles (SmokeScreen Trial)

N/A

Recruiting

Led By David B Peden, M.D., M.S.

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test for females who are not s/p hysterectomy with oopherectomy

A POST-bronchodilator increase in FEV1 of at least 12%, OR a clinical history of asthma after the age of 6 for Allergic Asthmatic Volunteers

Must not have

Symptomatic allergic rhinitis or current active allergies

Current symptoms of Covid infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 hours and 24 hours post exposure

Awards & highlights

Summary

This trial is testing a screening protocol to see if a person's GSTM1 genotype makes them more likely to have an inflammatory response to wood smoke particles.

Who is the study for?

This trial is for people aged 18-45 with mild asthma or allergies, who have good lung function and a low risk of cardiovascular disease. They must not smoke much, be willing to stop certain asthma medications temporarily, avoid caffeine before visits, and use reliable contraception if sexually active.

What is being tested?

Researchers are testing how wood smoke particles (WSP) affect inflammation in the lungs, particularly looking at whether a genetic factor (GSTM1 null genotype) influences this response. The study aims to identify individuals who are more or less responsive to WSP-induced inflammation.

What are the potential side effects?

The trial involves exposure to wood smoke particles which may cause respiratory symptoms like coughing or wheezing in susceptible individuals. There might also be an increased inflammatory response especially in those with a specific genetic makeup.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or have had a hysterectomy with oopherectomy.

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My lung function improved by at least 12% after treatment, or I was diagnosed with asthma after age 6.

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I have asthma or symptoms like wheezing and chest tightness.

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I am allergic to specific allergens and have symptoms or a positive skin test.

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My asthma is mild, under control, and I can stop my asthma medication for 2 weeks.

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I am between 18 and 45 years old.

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I have never been diagnosed with asthma or had symptoms like wheezing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have symptoms of allergic rhinitis or active allergies.

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I am currently experiencing symptoms of Covid.

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My doctor has diagnosed me with asthma.

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My asthma worsens more than twice a week, indicating moderate or severe asthma.

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I need albuterol daily for my asthma symptoms.

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I experience coughing or wheezing at night more than once a week.

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I have been intubated for asthma before.

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I have unusual physical signs like high fever, abnormal blood pressure, or low oxygen levels.

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I have moderate or severe asthma.

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I am not willing to use birth control methods if I am sexually active.

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I have no injuries or conditions that stop me from using a bike or treadmill.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 hours and 24 hours post exposure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 hours and 24 hours post exposure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 hours and 24 hours post exposure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Change in % neutrophils in induced sputum, comparing the 24 hr post wood smoke exposure to the baseline and the change in % neutrophils from 24 hr to 4 hr post wood smoke exposure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Woodsmoke ExposureExperimental Treatment1 Intervention

0 / 18Eligibility criteria met

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,543 Previous Clinical Trials

4,248,882 Total Patients Enrolled

4 Trials studying Bronchitis

3,106 Patients Enrolled for Bronchitis

National Institute of Environmental Health Sciences (NIEHS)NIH

289 Previous Clinical Trials

1,232,695 Total Patients Enrolled

3 Trials studying Bronchitis

63,267 Patients Enrolled for Bronchitis

David B Peden, M.D., M.S.Principal InvestigatorProfessor

~10 spots leftby May 2025

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