ClinicalTrials.gg
RecruitingNCT03859050Updated May 6, 2025

Alveolar Macrophage Programming Following Endotoxin Exposure

An interventional study of bronchoscopy with intrabronchial administration of lipopolysaccharide in ARDS, Human, sponsored by National Jewish Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-06.

Sponsored by National Jewish Health · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2019; still recruiting 7 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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).

02

Conditions studied

  • ARDS, Human
03

In context

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

This study's planned enrollment of 25 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

National Jewish Health is the lead sponsor of 109 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written,
  2. Age 18-50

Exclusion criteria

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. state (, 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 at time of screening
  10. Pregnant (based on urine pregnancy test) or breast feeding
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    LPS arm

    Other: bronchoscopy with intrabronchial administration of lipopolysaccharide

Interventions

  • Otherbronchoscopy 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2019 (actual). Primary completion is estimated for Jul 2029, 124 months after the start.

Of 263 non-industry interventional studies with no phase under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 124 months is above that.

Counting every sponsor, half of 270 studies reached it within 24 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2019
First posted
Mar 1, 2019
StartActual
Mar 18, 2019
Primary completionEst.
Jul 2029
CompletionEst.
Jul 2032
Last update
May 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03859050
Responsible party
Sponsor
First posted
Mar 1, 2019
Start date
Mar 18, 2019
Primary completion
Jul 2029 (estimated)
Completion
Jul 2032 (estimated)
Last update
May 6, 2025

Study contacts

Kara Mould
Contact
mouldk@njhealth.org
303-398-1787

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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