Alveolar Macrophage Programming Following Endotoxin Exposure

NCT ID: NCT03859050

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2032-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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ARDS, Human

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LPS arm

Group Type EXPERIMENTAL

bronchoscopy with intrabronchial administration of lipopolysaccharide

Intervention Type 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.

Interventions

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bronchoscopy with intrabronchial administration of lipopolysaccharide

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Written, informed consent
2. Age 18-50

Exclusion Criteria

1. Current or recent illness (past 2 weeks)
2. Presence or prior history of cardiac, pulmonary or systemic disease
3. Bleeding disorder, use of systemic anticoagulants or antiplatelet therapy
4. American Society of Anesthesiology (ASA) class 2 or greater
5. Immunocompromised state (HIV, immunoglobulin deficiency, systemic immunosuppressants)
6. 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
7. Alcohol use disorder or greater than 7 drinks/week for women or greater than 14 drinks/week for men in the past 3 months
8. Allergy or prior adverse reaction to lidocaine, midazolam or fentanyl
9. Abnormal spirometry or electrocardiogram at time of screening
10. Pregnant (based on urine pregnancy test) or breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kara Mould

Role: CONTACT

303-398-1787

Facility Contacts

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Kara Mould

Role: primary

303-398-1787

Other Identifiers

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HS-3131

Identifier Type: -

Identifier Source: org_study_id

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