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Clinical Trials/NCT03859050
NCT03859050RecruitingNot Applicable

Alveolar Macrophage Programming Following Endotoxin Exposure

National Jewish Health1 site in 1 country25 target enrollmentStarted: March 18, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
25
Locations
1
Primary Endpoint
Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Written, informed consent

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

Arms & Interventions

LPS arm

Experimental

Intervention: bronchoscopy with intrabronchial administration of lipopolysaccharide (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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