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Alveolar Macrophage Programming Following Endotoxin Exposure

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ClinicalTrials.gov Identifier: NCT03859050
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
National Jewish Health

Study Description
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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).

Condition or disease Intervention/treatment Phase
ARDS, Human Other: bronchoscopy with intrabronchial administration of lipopolysaccharide Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Alveolar Macrophage Programming Following Endotoxin Exposure
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LPS arm Other: 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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859050


Contacts
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Contact: Christine Griesmer 303-398-1325 griesmerc@njhealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Christine Griesmer    303-398-1325      
Sponsors and Collaborators
National Jewish Health
More Information
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT03859050    
Other Study ID Numbers: HS-3131
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders