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Effects of Bronchial Segmental Endotoxin Instillation in Humans

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 243 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Re-verified, no change to tracked fields
  3. Minor New version filed on ClinicalTrials.gov
  4. Minor 23 versions Re-verified since May 31, 2025, no change to tracked fieldsv218-v240
  5. Notable Trial status: Suspended to Enrolling by Invitation
    • Enrollment target: 41 to 58
    v217
Show 23 earlier versionsHide 23 earlier versions
  1. Notable Primary and study completion dates: Jun 30, 2025 to Jun 30, 2027
    • Enrollment target: 39 to 41
    v216
  2. Minor 6 versions Re-verified since Mar 14, 2025, no change to tracked fieldsv210-v215
  3. Minor Enrollment target: 32 to 39v209
  4. Minor 3 versions Re-verified since Sep 7, 2024, no change to tracked fieldsv206-v208
  5. Stopped Trial status: Recruiting to Suspended Sponsor's reason: The expiration date of the endotoxin used under IND. The sponsor has requested that there be a clinical hold placed on the study until the…
    • Enrollment target: estimated 58 to confirmed 32
    v205
  6. Notable Primary and study completion dates: Jun 30, 2024 to Jun 30, 2025v204
  7. Minor 10 versions Re-verified since Apr 17, 2024, no change to tracked fieldsv194-v203
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: \- When bacteria enter the lungs, serious infections can occur. Researchers want to learn more about the process of inflammation in the lungs by studying lung cells and the products that they make. Lung cells are influenced by infections, smoking, and molecules made within the body. Researchers also want to learn more about one of these molecules, called microRNA (or micro ribonucleic acid). Objective: \- To better how the body responds to infection. Also, to understand which cells in the lung secrete microRNA and how they may influence other lung cells. Eligibility: \- Healthy, non-smoking adults ages 18-45. Design: * Participants will be screened with a medical history and physical exam. They will have blood and urine tests and an electrocardiogram. * Participants will have blood drawn from an arm vein. They will have an intravenous catheter (small plastic tube) placed in a vein. * All participants will have bronchoscopy with bronchoalveolar lavage. They will be numbed with medicine. A thin flexible tube will be placed through the nasal passages or the mouth into the airways of the lung. * Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the airways with salt water) in order to obtain cells from lung. The water will then be suctioned out. * Some participants will have two bronchoscopies; during the first procedure, endotoxin, a molecule found in bacteria is squirted into a small portion of the lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6 to 48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at the lung s response to endotoxin. * Participants heart rhythm and rate, temperature and blood oxygen level will be monitored during the procedures. * Participants will be called the next day to see how they are feeling.
Trial Details
NCT Number NCT02392442
Lead Sponsor National Institutes of Health Clinical Center (CC)
Conditions
(from sponsor)
Acute Lung Inflammation
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov