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NCT Number: NCT03859050

Alveolar Macrophage Programming Following Endotoxin Exposure

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).

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Location status: Recruiting

Location contact

Kara Mould

CONTACT

303-398-1787

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written, informed consent
  • Age 18-50

Exclusion criteria

  • 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

Treatment and study plan

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.

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

    Time frame: 7 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kara Mould

CONTACT

[email protected]

303-398-1787

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2029
Study completion
2032
First posted
Mar 1, 2019
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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