Back to resultsAlveolar Macrophage Programming Following Endotoxin Exposure
Primary Purpose
ARDS, Human
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bronchoscopy with intrabronchial administration of lipopolysaccharide
Sponsored by
About this trial
This is an interventional basic science trial for ARDS, Human
Eligibility Criteria
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
Sites / Locations
- National Jewish HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LPS arm
Arm Description
Outcomes
Primary Outcome Measures
Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated
Resident and recruited macrophages will be purified using fluorescence activated cell sorting (FACS) and subjected to RNA sequencing.
Secondary Outcome Measures
Full Information
NCT ID
NCT03859050
First Posted
February 14, 2019
Last Updated
August 19, 2019
Sponsor
National Jewish Health
1. Study Identification
Unique Protocol Identification Number
NCT03859050
Brief Title
Alveolar Macrophage Programming Following Endotoxin Exposure
Official Title
Alveolar Macrophage Programming Following Endotoxin Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LPS arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
bronchoscopy with intrabronchial administration of lipopolysaccharide
Intervention Description
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 Information:
Title
Resident alveolar macrophages and recruited macrophages will be distinguished from one another using multi-parameter flow cytometry, and the relative proportions enumerated
Description
Resident and recruited macrophages will be purified using fluorescence activated cell sorting (FACS) and subjected to RNA sequencing.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Griesmer
Phone
303-398-1325
Email
griesmerc@njhealth.org
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Griesmer
Phone
303-398-1325
12. IPD Sharing Statement
Learn more about this trial
Alveolar Macrophage Programming Following Endotoxin Exposure
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