Alveolar Macrophage Programming Following Endotoxin Exposure

ARDS, Human Clinical Trial

Official title:

Alveolar Macrophage Programming Following Endotoxin Exposure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03859050
• Other study ID #: HS-3131
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: March 2024

Study information

• Verified date: August 2019
• Source: National Jewish Health
• Contact: Christine Griesmer
• Phone: 303-398-1325
• Email: griesmerc[@]njhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome, Adult

Intervention

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.

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days