Effects of Bronchial Segmental Endotoxin Instillation in Humans

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Mar 18, 2015

Keywords

ClinConnect Summary

Defining the mechanisms that limit tissue injury during acute inflammation may provide the basis for preventing secondary organ dysfunction during serious infections. We plan to use the human endotoxin lung challenge model to study mechanisms associated with the initiation and resolution of lung inflammation.

Endotoxin (LPS), an outer membrane component of Gram-negative bacteria, is a major microbial factor that mediates inflammation associated with serious infections. For over fifty years, endotoxin has been administered to humans as a challenge agent in order to understand basic mechanis...

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Eligibility criteria

• * INCLUSION CRITERIA:
• • 1. Healthy 18 to 45 year old, nonsmoking subjects based on screening examination and laboratory tests.
• • 2. No significant active medical problems. This would include but not be limited to any cardiac disorder (e.g. arrhythmia, valvular heart disease), pulmonary disease (e.g. asthma requiring chronic medications, chronic bronchitis, emphysema), neurologic disorder (e.g.
• • epilepsy), kidney disease (e.g. nephritis, nephrosis), rheumatologic disorder (e.g. inflammatory arthritis), endocrine disorder (e.g. diabetes, thyroid disease), liver disease (e.g. hepatitis), gastrointestinal disorder (e.g. inflammatory bowel disease) or infectious
• • disease (e.g. human immunodeficiency virus).
• • 3. No concurrent medications including aspirin or non-steroidal anti-inflammatory drugs or have not taken these for at least 7 days prior to study participation.
• • 4. Previous smokers would have to have abstained from cigarettes for at least one year and have no greater than a 10-pack year smoking history. If you use a hookah, e-cigarette, or vaping more than once a week, you must abstain for at least 6 weeks prior to participating in the study.
• • 5. Females must be practicing active method of birth control or abstinence of sexual activity.
• • 6. Must be willing to have samples stored
• EXCLUSION CRITERIA:
• • 1. Any serious active medical problem as defined above
• • 2. Pregnancy and/or lactation
• • 3. BMI \>30