Airway InflammationSmokeScreenNCT02767973
To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility
A study testing Wood Smoke Particles (WSP) in people with Airway Inflammation and Allergic Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Inflammation, Allergic Asthma
- What is being tested?
- Wood Smoke Particles (WSP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2016to May 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Specific for Healthy Volunteers
- 4. No history of episodic wheezing, chest tightness or shortness of breath consistent with asthma, or physician diagnoses asthma.
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- 5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70
- Specific for Allergic Asthmatic Volunteers
- 6. History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.
- 7. A POST-bronchodilator increase in FEV1 of at least 12%, OR a clinical history of asthma after the age of 6.
- 8. FEV1 of at least 75% of predicted without use of short acting bronchodilating medications for 12 hours, consistent with lung function of persons with no more than mild episodic or mild persistent asthma.
- 9. Mild persistent asthmatics must be well controlled (in accordance with NHLBI guidelines) and willing to discontinue Singulair, inhaled corticosteroids or cromolyn for a period of 2 weeks prior to study visits (except for use of cromolyn exclusively prior to exercise)
- 10. Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response; or a clinical history consistent with seasonal or perennial allergy symptoms.
- 11. Subjects must be willing to avoid caffeine for 12 hours prior to all visits.
- Allergy skin testing are performed as part of IRB98-0799, which a subject must complete in order to be considered for this protocol.
Who cannot join
- Patients who meet any of these criteria are not eligible for enrollment as study participants:
- 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.
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge.
- Abnormal physical findings at the baseline visit, including but not limited to abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading less than 94%.
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- Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
- Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS. Oral contraceptives are acceptable, as are Antidepressants and other medications may be permitted if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety and if the dosage has been stable for 1 month
- Orthopedic in juries or impediments that would preclude bicycle or treadmill exercise.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Medications which may impact the results of the WSP exposure, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents).
- Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal medications in the 4 days prior to the screening visit the exposure session.
- Symptomatic allergic rhinitis or current active allergies.
- Cigarette smoking > 1 pack per month
- Current symptoms of Covid infection
- Positive Covid test in the past 90 days
- Specific for Healthy Volunteers
- Physician diagnosis of asthma.
- Specific for Asthmatic Volunteers
- Physician directed emergency treatment for an asthma exacerbation within the preceding 3 months
- Moderate or Severe asthma
- Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
- Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
- Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma
- History of intubation for asthma
- Use of systemic steroid therapy within the preceding 3 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.
- Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or Zafirlukast) except for use of cromolyn exclusively prior to exercise.
- Use of daily theophylline within the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center For Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
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.
Read the detailed description
Particulate matter (PM) is a leading cause of respiratory tract and cardiovascular disease in the United States and world-wide. Wood smoke particles (WSP) derived from wild land and other fires account for a significant fraction of ambient air PM. Health effects associated with WSP include acute bronchitis, asthma exacerbation, pneumonia, cough and systemic inflammation. While these effects are seen in both healthy and asthmatic individuals, many studies indicate that asthmatics have increased susceptibility to the effects of WSP. Though WSP-related effects on cardiovascular (CV) disease are less well documented, WSP do contribute to PM levels, and PM exposure is linked to CV health effects (changes in heart rate variability, vascular reactivity, and lipid profiles). WSP from wild land fires can cause abrupt increases in ambient air PM 2.5 levels (mean levels ~250µg/m3, peak levels >1000 µg/m3). Avoidance of rapidly increasing PM air pollution due to wild land fires is not feasible, as many people cannot leave the burn region.
This is a screening protocol to ensure that there ultimately will be adequate subjects available for testing gamma tocopherol in an appropriate population. It will identify volunteers who have a ≥10% increase in %PMNs following WSP challenge over baseline values (SA1). This screening procedure will identify various risk factors that may increase risk of experiencing airway inflammation and related adverse health outcomes following WSP exposure. The GSTM1- genotype is a risk factor that has been extensively explored. Researchers at the CEMALB have reported that GSTM1- healthy volunteers (HVs) have increased inflammatory and systemic responses to O3 and various components of PM (LPS70 and Diesel exhaust particles). Using the 10% increase in %PMNs to define PMN responsiveness, results showed that GSTM1- volunteers had a 13 fold higher risk of being PMN responders to 0.06 ppm O3. When examining %PMNs as a continuous measure, it was observed that GSTM1- volunteers have increased airway PMN response O3 as well as increased airway and systemic PMN response to LPS70.
The researchers at the CEMALB have also examined various response features of 27 individuals (13 healthy, 4 allergic non asthmatics, 10 allergic asthmatics) defined as being responsive (R, n=18) or non-responsive (NR, n=9) to O3 based on airway PMN influx (%PMNs). Among the factors explored were inflammatory responses, baseline characteristics and gene expression profiles in recovered sputum cells. The researchers have also observed that within individuals, PMN response to O3 and LPS correlate, and anticipate that WSP will induce inflammatory responses via mechanisms similar to those for these pollutants.
- Conditions
- Airway Inflammation, Allergic Asthma
- Being tested
- Wood Smoke Particles (WSP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wood Smoke Particles (WSP)Other
After baseline (pre-exposure) assessment (which includes recovery of induced sputum), these volunteers will then undergo an exposure to 500μg/m3 wood smoke particles for 2 hours, with alternating 15 min of exercise (cycle ergometer) with 15 min rest to achieve 25 l/m2 body surface/min minute ventilation, followed by sputum induction after 6 and 24 hours after initiation of the challenge.
| Study group | Role | What they receive |
|---|---|---|
| Woodsmoke Exposure | Experimental | Not described Receives: Other: Wood Smoke Particles (WSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in % neutrophils in induced sputum, comparing the 4 hr post wood smoke exposure to the baseline
Induced sputum will be collected and % neutrophils will be measured after each exposure and will be compared to baseline and each other.
Measured: 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
Quantitative RT PCR will be used to measure the presence or absence of the GSTM1 transcript from blood obtained by venipuncture
Measured: baseline, and 4 hours post exposure
Secondary outcomes (1)
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
Induced sputum will be collected and % neutrophils will be measured after each exposure and will be compared to baseline and each other.
Measured: baseline, 4 hours and 24 hours post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start9 Jun 2016
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: We no longer have access to the Wood smoke chamber and will need to rework how we do the wood smoke exposures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway InflammationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- David B Peden, M.D., M.S., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767973
- Sponsor's protocol ID
- 15-1775
- Other IDs
- 1R01ES025124-01A1
- Acronym
- SmokeScreen
- Status last verified
- Aug 2026
- First submitted
- 3 May 2016
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1 and Other Factors in This Susceptibility
- ClinicalTrials.gov ID
- NCT02767973
- Acronym / sponsor ID
- SmokeScreen / 15-1775
- Conditions
- Airway Inflammation, Allergic Asthma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: We no longer have access to the Wood smoke chamber and will need to rework how we do the wood smoke exposures.
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 9 Jun 2016 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Particulate matter (PM) is a leading cause of respiratory tract and cardiovascular disease in the United States and world-wide. Wood smoke particles (WSP) derived from wild land and other fires account for a significant fraction of ambient air PM. Health effects associated with WSP include acute bronchitis, asthma exacerbation, pneumonia, cough and systemic inflammation. While these effects are seen in both healthy and asthmatic individuals, many studies indicate that asthmatics have increased susceptibility to the effects of WSP. Though WSP-related effects on cardiovascular (CV) disease are less well documented, WSP do contribute to PM levels, and PM exposure is linked to CV health effects (changes in heart rate variability, vascular reactivity, and lipid profiles). WSP from wild land fires can cause abrupt increases in ambient air PM 2.5 levels (mean levels ~250µg/m3, peak levels >1000 µg/m3). Avoidance of rapidly increasing PM air pollution due to wild land fires is not feasible, as many people cannot leave the burn region.
This is a screening protocol to ensure that there ultimately will be adequate subjects available for testing gamma tocopherol in an appropriate population. It will identify volunteers who have a ≥10% increase in %PMNs following WSP challenge over baseline values (SA1). This screening procedure will identify various risk factors that may increase risk of experiencing airway inflammation and related adverse health outcomes following WSP exposure. The GSTM1- genotype is a risk factor that has been extensively explored. Researchers at the CEMALB have reported that GSTM1- healthy volunteers (HVs) have increased inflammatory and systemic responses to O3 and various components of PM (LPS70 and Diesel exhaust particles). Using the 10% increase in %PMNs to define PMN responsiveness, results showed that GSTM1- volunteers had a 13 fold higher risk of being PMN responders to 0.06 ppm O3. When examining %PMNs as a continuous measure, it was observed that GSTM1- volunteers have increased airway PMN response O3 as well as increased airway and systemic PMN response to LPS70.
The researchers at the CEMALB have also examined various response features of 27 individuals (13 healthy, 4 allergic non asthmatics, 10 allergic asthmatics) defined as being responsive (R, n=18) or non-responsive (NR, n=9) to O3 based on airway PMN influx (%PMNs). Among the factors explored were inflammatory responses, baseline characteristics and gene expression profiles in recovered sputum cells. The researchers have also observed that within individuals, PMN response to O3 and LPS correlate, and anticipate that WSP will induce inflammatory responses via mechanisms similar to those for these pollutants.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woodsmoke Exposure | Experimental | Other: Wood Smoke Particles (WSP) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
- Specific for Healthy Volunteers
Key exclusion criteria (28 listed)
- Patients who meet any of these criteria are not eligible for enrollment as study participants:
- Clinical contraindications:
- Specific for Healthy Volunteers
- Specific for Asthmatic Volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wood Smoke Particles (WSP)After baseline (pre-exposure) assessment (which includes recovery of induced sputum), these volunteers will then undergo an exposure to 500μg/m3 wood smoke particles for 2 hours, with alternating 15 min of exercise (cycle ergometer) with 15 min rest to achieve 25 l/m2 body surface/min minute ventilation, followed by sputum induction after 6 and 24 hours after initiation of the challenge. | Other | Woodsmoke Exposure |
Primary outcome
Change in % neutrophils in induced sputum, comparing the 4 hr post wood smoke exposure to the baseline
Time frame: baseline, and 4 hours post exposure
Induced sputum will be collected and % neutrophils will be measured after each exposure and will be compared to baseline and each other.
Change from baseline in post wood smoke airway neutrophil influx between GSTM1 null genotype compared to GSTM1 sufficient subjects
Time frame: baseline, and 4 hours post exposure
Quantitative RT PCR will be used to measure the presence or absence of the GSTM1 transcript from blood obtained by venipuncture
1 secondary outcome
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
Time frame: baseline, 4 hours and 24 hours post exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Peden, M.D., M.S. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wood Smoke Particles (WSP) in people with Airway Inflammation and Allergic Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in % neutrophils in induced sputum, comparing the 4 hr post wood smoke exposure to the baseline (time frame: baseline, and 4 hours post exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.