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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

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alveolar Macrophage Programming Following Endotoxin Exposure
Official Title  ICMJE Alveolar Macrophage Programming Following Endotoxin Exposure
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE ARDS, Human
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: LPS arm
Intervention: Other: bronchoscopy with intrabronchial administration of lipopolysaccharide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Christine Griesmer 303-398-1325 griesmerc@njhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859050
Other Study ID Numbers  ICMJE HS-3131
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Jewish Health
Study Sponsor  ICMJE National Jewish Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Jewish Health
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP