Cytochrome P450 Epoxygenase Pathway Regulation of Macrophage Function

Completed

Conditions studied: Polymorphism, Lung Inflammation

In brief

Background: Respiratory diseases affect more than 1 billion people worldwide. They are a growing public health concern. The lungs are constantly exposed to environmental factors such as dust, fumes, microbes, and pollutants. But much is still not known about how these pollutants lead to respiratory illnesses. Researchers want to collect samples from lungs and blood to see how genetics and environmental pollutants affect cellular responses or functioning. Objectives: To study how cytochrome P450 epoxygenase pathway enzymes affect macrophage function in the lungs and inflammatory responses. Eligibility: Adults ages 18 65 who can have a bronchoscopy. Design: All study visits will take place at the NIEHS Clinical Research Unit in Research Triangle Park, NC. At study visit 1, participants will be screened with medical history and physical exam. They will have blood and urine tests. They will take tests that measure their lung function. They will answer questionnaires. Before the visit, they will be given a list of medicines they cannot take. They also must not have caffeine on the day of their visit. The visit will last about 3 hours. At study visit 2, participants will give blood samples. They will undergo bronchoscopy. For this, they will get an intravenous line in a vein to get sedatives. Their airways will be numbed. Cells will be collected from their lungs. They will fast for 8 hours before the visit. They must have someone else drive them home from the visit. The visit will last about 3-4 hours. Participants will get a follow-up phone call about 1 day after study visit 2. ...

Key facts

Study ID

NCT02743468

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

20

Starts

2019-01-08

Expected to finish

2023-09-21

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Current pregnancy or lactation, as medications used during the bronchoscopy can be excreted in the breast milk of lactating mothers
• Current smoker or significant second-hand smoke exposure (defined by urine cotinine >200 ng/mL at screening)
• Post-bronchodilator FEV1 < 70% of predicted
• For asthmatics, any indication of moderate or severe asthma such as:
• Physician-directed emergency treatment for an asthma exacerbation within the preceding 12 months
• Any use of systemic steroid therapy during the last year or continuous use of inhaled steroids over a period of 1 month or longer during the past 6 months
• Regular use of cromolyn (except for prophylaxis of exercise induced bronchospasm) or any use of leukotriene inhibitors (Montelukast or Zafirlukast) within the past month
• Symptoms including:
• Night-time symptoms of cough or wheeze greater than 1x/week
• Exacerbations of asthma more than 2x/week
• Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness)
• Bleeding disorders or regular use of aspirin or other non-steroidal anti-inflammatory drugs (which inhibit platelet function) or other drugs that prolong bleeding time such as warfarin, heparin or derivatives, or clopidogrel and related ADP inhibitors
• Sickle cell disease or GP6 deficiency
• Facial deformity or major facial surgery
• Asthma exacerbation or respiratory infection 4 weeks prior to study visit
• Allergy or history of adverse reactions to lidocaine, midazolam, or fentanyl
• Vital signs (temperature, blood pressure, pulse rate) that are outside of the established CRU limits
• Body weight <50 kg (<110 lbs)
• The following abnormal clinical laboratory values (obtained during Visit 1 assessment):
• Platelet count <100,000 per L
• White blood cells count <3000 per L
• Absolute neutrophil count <1000 per L
• Hematocrit <35% for both female and male
• PT/INR and PTT based on reference laboratory established reference ranges
• Serum creatinine >1.4 mg/dL

Where it is running

• NIEHS, Research Triangle Park — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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