Intrabronchial Lipopolysaccharide for Acute Respiratory Distress Syndrome

Overseen By Kara Mould

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: National Jewish Health

Must not be taking: Anticoagulants, Antiplatelets, Immunosuppressants, others

Disqualifiers: Cardiac, Pulmonary, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use systemic anticoagulants, antiplatelet therapy, or systemic immunosuppressants.

What data supports the effectiveness of the treatment Bronchoscopy, Bronchoscopy, Flexible Bronchoscopy for Acute Respiratory Distress Syndrome?

Flexible bronchoscopy is considered a valuable tool in the intensive care unit for both diagnostic and therapeutic purposes, as it allows for the visualization of airways and sampling for diagnosis with relatively few complications. It has been used safely in critically ill patients, including those with respiratory complications, suggesting its potential usefulness in managing conditions like acute respiratory distress syndrome. ^{1 2 3 4 5}

How does the treatment using bronchoscopy differ from other treatments for acute respiratory distress syndrome?

Bronchoscopy, particularly flexible bronchoscopy, is unique in that it allows direct visualization and access to the airways, which can help diagnose and manage respiratory conditions. Unlike other treatments that may focus on medication or external support, bronchoscopy can provide detailed information about the lungs and assist in targeted interventions, although it may temporarily affect lung ventilation during the procedure. ^{3 6 7 8 9}

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for healthy adults aged 18-50 who haven't used alcohol excessively or any inhaled substances recently. Pregnant or breastfeeding individuals, those with bleeding disorders, immunocompromised conditions, recent illnesses, heart/lung/systemic diseases, abnormal lung function tests or ECGs can't participate.

Inclusion Criteria

Written, informed consent

Exclusion Criteria

I have a bleeding disorder or I'm on blood thinners.

I have a weakened immune system due to a condition like HIV or medication.

You have been drinking a lot of alcohol in the past 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are exposed to endotoxin and macrophage activity is assessed

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Bronchoscopy

Trial Overview The study involves a bronchoscopy procedure where lipopolysaccharide (a substance that can cause inflammation) is directly placed into the lungs to understand how different types of macrophages contribute to lung repair after injury.

Participant Groups

Group I: LPS arm Experimental Treatment 1 Intervention

Bronchoscopy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Bronchoscopy for:

• Diagnostic purposes
• Therapeutic interventions
• Airway management

Approved in European Union as Bronchoscopy for:

• Diagnostic purposes
• Therapeutic interventions
• Airway management

Approved in Canada as Bronchoscopy for:

• Diagnostic purposes
• Therapeutic interventions
• Airway management

Who Is Running the Clinical Trial?

National Jewish Health

Lead Sponsor

Trials

145

Recruited

318,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Can fiberoptic bronchoscopy be applied to critically ill patients treated with noninvasive ventilation for acute respiratory distress syndrome? Prospective observational study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Changes in the inflammatory response of the lung during acute respiratory distress syndrome: prognostic indicators. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Clinical course and complications following diagnostic bronchoalveolar lavage in critically ill mechanically ventilated patients. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Flexible bronchoscopy for children on extracorporeal membrane oxygenation for cardiac failure. [2011]

5. England pubmed.ncbi.nlm.nih.gov

The use of bronchoscopy in critically ill patients: considerations and complications. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Role of endoscopy in the diagnosis of respiratory distress]. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The effect of fibreoptic bronchoscopy in acute respiratory distress syndrome: experimental evidence from a lung model. [2020]

8. India pubmed.ncbi.nlm.nih.gov

Comparative evaluation of propofol and combination of propofol-dexmedetomidine in adjunct with topical airway anesthesia for rigid bronchoscopy: A randomized double-blinded prospective study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Wall-mounted Versus Handheld Syringe Suction for Pediatric Bronchoalveolar Lavage: A Randomized Controlled Trial. [2023]