32 Participants Needed

Inhaled Carbon Monoxide for Acute Respiratory Distress Syndrome (ARDS)

Recruiting at 6 trial locations
LE
RB
Overseen ByRebecca Baron, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducted at 7 tertiary care medical centers including Weill Cornell Medicine/NewYork-Presbyterian Hospital, Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH), Duke University Hospital, Durham Veterans Administration Medical Center, New York-Presbyterian Brooklyn Methodist Hospital, and Duke Regional Hospital. The purpose of this study is to evaluate the safety, tolerability, and efficacy of inhaled carbon monoxide (iCO) for the treatment of ARDS and to examine the biologic readouts of low dose iCO therapy in patients with ARDS

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants using certain therapies like inhaled pulmonary vasodilators, so it's best to discuss your specific medications with the trial team.

Is inhaled carbon monoxide generally safe for humans?

Research suggests that low-dose inhaled carbon monoxide may have anti-inflammatory effects and could be safe for use in conditions like COPD, as it was associated with a decreased risk of hospitalization. However, more studies are needed to confirm its safety in humans, especially for different conditions like ARDS.12345

How is inhaled carbon monoxide treatment different from other treatments for ARDS?

Inhaled carbon monoxide (CO) is unique because it is being explored for its potential protective effects on cells in ARDS, a condition with no effective drug treatments. Unlike other therapies, it is administered as a gas directly into the lungs, which is different from typical drug treatments that are often given orally or intravenously.13678

What data supports the effectiveness of the treatment inhaled carbon monoxide for acute respiratory distress syndrome (ARDS)?

Research suggests that low-dose inhaled carbon monoxide may protect lung cells and reduce inflammation and stress in conditions similar to ARDS, like sepsis and acute lung injury. These protective effects have been observed in laboratory studies, indicating potential benefits for ARDS patients.19101112

Who Is on the Research Team?

RB

Rebecca Baron, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with ARDS, which is a severe lung condition. Participants must be intubated, have specific oxygenation and chest X-ray criteria, and not explained by heart failure. Exclusions include pregnancy, recent heart attacks or strokes, certain religious beliefs against blood transfusion, low hemoglobin levels, and unwillingness to follow the study's procedures.

Inclusion Criteria

ARDS is defined when all four of the following criteria are met:
A PaO2/FiO2 ratio ≤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP)
Bilateral opacities on frontal chest radiograph (not fully explained by effusions, lobar/lung collapse, or nodules) within 1 week of a known clinical insult or new or worsening respiratory symptoms
See 3 more

Exclusion Criteria

Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization
No arterial or central line/no intent to place an arterial or central line
Diffuse alveolar hemorrhage from vasculitis
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive inhaled carbon monoxide or medical air for up to 90 minutes daily for 3 days

1 week
Daily visits for 3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days
Regular monitoring visits

Long-term Follow-up

Participants are assessed for long-term outcomes such as hospital-free days and cognitive assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Inhaled Carbon Monoxide
Trial Overview The study tests inhaled carbon monoxide (iCO) at 200 ppm versus medical air to see if iCO can safely treat ARDS. It's conducted across several hospitals and includes patients randomly assigned to either treatment without knowing which one they receive (partially double-blind).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inhaled Carbon MonoxideExperimental Treatment1 Intervention
Group II: Medical airPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

Durham VA Medical Center

Collaborator

Trials
40
Recruited
9,300+

New York Presbyterian Brooklyn Methodist Hospital

Collaborator

Trials
21
Recruited
3,900+

Duke Regional Hospital

Collaborator

Trials
2
Recruited
2,400+

Duke Regional Hospital

Collaborator

Trials
2
Recruited
2,400+

U.S. Army Medical Research Acquisition Activity

Collaborator

Trials
26
Recruited
10,500+

Published Research Related to This Trial

In a multicenter trial involving 326 patients with acute respiratory distress syndrome (ARDS), intravenous salbutamol treatment was associated with increased 28-day mortality, with 34% of patients in the salbutamol group dying compared to 23% in the placebo group.
Due to safety concerns and the lack of benefit, the trial was stopped early, indicating that salbutamol is unlikely to be a safe or effective treatment for ARDS, and further studies on beta-agonists in this context are not recommended.
Beta-Agonist Lung injury TrIal-2 (BALTI-2): a multicentre, randomised, double-blind, placebo-controlled trial and economic evaluation of intravenous infusion of salbutamol versus placebo in patients with acute respiratory distress syndrome.Gates, S., Perkins, GD., Lamb, SE., et al.[2022]
Inhaled nitric oxide (iNO) therapy is more effective in ARDS patients with a greater amount of normal lung tissue surrounding small consolidated areas, as indicated by a significant correlation between the morphology of lung injury and the response to iNO.
Patients who did not respond to iNO therapy had larger, more coherently consolidated lung regions, suggesting that the distribution of lung injury plays a crucial role in the efficacy of iNO treatment.
[Computed tomographic criteria as expected effect to inhaled nitric oxide in patients with severe acute respiratory distress syndrome].Röttgen, R., Busch, T., Lohbrunner, H., et al.[2020]

Citations

A phase I trial of low-dose inhaled carbon monoxide in sepsis-induced ARDS. [2022]
Beta-Agonist Lung injury TrIal-2 (BALTI-2): a multicentre, randomised, double-blind, placebo-controlled trial and economic evaluation of intravenous infusion of salbutamol versus placebo in patients with acute respiratory distress syndrome. [2022]
Inhaled nitric oxide does not reduce mortality in patients with acute respiratory distress syndrome regardless of severity: systematic review and meta-analysis. [2022]
Carbon monoxide in acute lung injury. [2019]
Inhaled carbon monoxide protects time-dependently from loss of hypoxic pulmonary vasoconstriction in endotoxemic mice. [2018]
Ambient carbon monoxide and the risk of hospitalization due to chronic obstructive pulmonary disease. [2022]
[Changes of carbon monoxide, nitric oxide levels and heme oxygenase system in acute respiratory distress syndrome induced by oleic acid]. [2020]
Anti-inflammatory effects of inhaled carbon monoxide in patients with COPD: a pilot study. [2022]
Association of ambient carbon monoxide exposure with hospitalization risk for respiratory diseases: A time series study in Ganzhou, China. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of inhaled carbon monoxide on acute lung injury in mice. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Inhaled nitric oxide in acute respiratory distress syndrome. [2020]
[Computed tomographic criteria as expected effect to inhaled nitric oxide in patients with severe acute respiratory distress syndrome]. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security