Alveolar Macrophage Programming Following Endotoxin Exposure

NCT03859050 | Recruiting

• 1 other identifier: HS-3131
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The histologic hallmarks of lung inflammation include accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

• Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated

  Resident and recruited macrophages will be purified using fluorescence activated cell sorting (FACS) and subjected to RNA sequencing.

  7 days

Study Arms (1)

LPS arm

EXPERIMENTAL

Other: bronchoscopy with intrabronchial administration of lipopolysaccharide

Interventions

bronchoscopy with intrabronchial administration of lipopolysaccharide OTHER

The PI will administer intrabronchial LPS into the lungs of healthy volunteers and then obtaining macrophages by bronchoalveolar lavage (BAL) 24, 48, 72, 96, or 120 hours later.

LPS arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written, informed consent
• Age 18-50

You may not qualify if:

• Current or recent illness (past 2 weeks)
• Presence or prior history of cardiac, pulmonary or systemic disease
• Bleeding disorder, use of systemic anticoagulants or antiplatelet therapy
• American Society of Anesthesiology (ASA) class 2 or greater
• Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants)
• Use of any inhaled substance, including tobacco, marijuana, e-cigarrettes, cocaine, methamphetamines, or toxic vapors in the past 3 months or greater than 10 pack-year smoking history
• Alcohol use disorder or greater than 7 drinks/week for women or greater than 14 drinks/week for men in the past 3 months
• Allergy or prior adverse reaction to lidocaine, midazolam or fentanyl
• Abnormal spirometry or electrocardiogram at time of screening
• Pregnant (based on urine pregnancy test) or breast feeding

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Kara Mould

CONTACT

303-398-1787; mouldk@njhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 1, 2019
• Study Start: March 18, 2019
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2032
• Last Updated: May 6, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)