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Effects of Bronchial Segmental Endotoxin Instillation in Humans

NCT02392442 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Acute Lung Inflammation

Interventions

OTHER

Saline

Investigate the changes in miRNA signatures found in BAL and lung cells from healthy volunteers at baseline and at 6 hours after 1800 of normal Saline installed in six 30 mL aliquots into the left (lingual) and right (middle lobe) lung segments (360 mL total).

BIOLOGICAL

Endotoxin

Investigate the changes in miRNA signatures found in BAL and lung cells from healthy volunteers at baseline and at 6, 24, or 48 hours after endotoxin segmental lung challenge.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Anthony F Suffredini, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-18
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392442 on ClinicalTrials.gov