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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 hours and 24 hours post exposure

Awards & highlights

SmokeScreen Trial 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.Check my eligibility

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.See study design

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.

SmokeScreen Trial 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.

SmokeScreen Trial 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

SmokeScreen Trial Design

1Treatment groups

Experimental Treatment

Group I: Woodsmoke ExposureExperimental Treatment1 Intervention

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,882 Total Patients Enrolled

4 Trials studying Bronchitis

3,106 Patients Enrolled for Bronchitis

National Institute of Environmental Health Sciences (NIEHS)NIH

284 Previous Clinical Trials

1,232,577 Total Patients Enrolled

3 Trials studying Bronchitis

63,267 Patients Enrolled for Bronchitis

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to become a participant in this trial?

"Participation in this trial necessitates the presence of inflammation and an age range between 18 to 45 years old. Up to 160 patients can partake in the study."

Answered by AI

Is the age criterion for this trial limited to individuals over 40 years of age?

"This particular trial seeks individuals between 18 and 45 years old. Conversely, there are 34 trials that offer services to minors and 275 for seniors over 65."

Answered by AI

How many individuals will be partaking in this clinical experiment?

"Affirmative. Research published on clinicaltrials.gov reveals that this research project, first posted in May 2016 and most recently edited November 2022, is actively seeking volunteers for enrollment. 160 participants are required from 1 trial site."

Answered by AI

Are there vacancies for participants in this investigation?

"Evidence from clinicaltrials.gov confirms that, as of November 15th 2022, this trial is still open to recruitment. It was initially announced on May 1st 2016 and has been regularly updated since then."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02767973.