Recruiting

Observational Study

Sponsor:

National Jewish Health

Code:

NCT03859050

Conditions

ARDS, Human

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

bronchoscopy with intrabronchial administration of lipopolysaccharide

Study Details

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

Study ID

NCT03859050

Start date

Mar 18, 2019

Status verified date

Jul, 2024

Completion date

Jul, 2032

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LPS arm

Interventions

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.

Primary outcome measure

  • Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Kara Mould

303-398-1787mouldk@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Kara Mould

303-398-1787

More Information

Sponsor

National Jewish Health

Last update posted

May 6, 2025

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2025-05-06.