To Identify Persons Who Are Susceptible to WSP-induced Inflammation and Examine the Role of GSTM1… (NCT02767973) | Clinical Trial Compass
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 range18 Years – 45 Years
SexALL
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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.
✕. 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%.
What they're measuring
1
Change in % neutrophils in induced sputum, comparing the 4 hr post wood smoke exposure to the baseline
Timeframe: baseline, and 4 hours post exposure
2
Change from baseline in post wood smoke airway neutrophil influx between GSTM1 null genotype compared to GSTM1 sufficient subjects
✕. 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.