NCT02425579

Safety Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)

A Phase I Trial of Inhaled Carbon Monoxide for the Treatment of Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS.

Detailed description

The acute respiratory distress syndrome (ARDS) is a syndrome of severe acute lung inflammation and hypoxemic respiratory failure with an incidence of 180,000 cases annually in the U.S.Despite decades of research and recent advances in lung protective ventilator strategies, morbidity and mortality remain unacceptably high. Furthermore, no specific effective pharmacologic therapies currently exist. The lack of specific effective therapies for sepsis-related ARDS indicates a need for new treatments that target novel pathways. Carbon monoxide (CO) represents a novel therapeutic modality in ARDS based on data obtained in experimental models of ARDS and sepsis over the past decade. CO has been shown to be protective in experimental models of Acute Lung Injury (ALI), including hyperoxia and endotoxin exposure, bleomycin, ischemia/reperfusion, and ventilator-induced lung injury (VILI). At low doses, CO has been shown to confer tissue protective effects in these ALI models. In addition, CO has been shown to decrease inflammation, enhance phagocytosis, and improve mortality in models of sepsis including endotoxemia, hemorrhagic shock, and cecal ligation and puncture (CLP). CO has also been shown to have beneficial therapeutic effects in pre-clinical models of disease including pulmonary hypertension, vascular injury, and transplantation. Furthermore, multiple human studies have demonstrated that experimental administration of several different concentrations of CO is well tolerated and that low dose inhaled CO can be safely administered to subjects in a controlled research environment. The purpose of this study is to assess the safety of inhaled CO therapy in mechanically ventilated patients with sepsis-induced ARDS.

Conditions

• Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
DRUG	Inhaled Carbon Monoxide at 100ppm (4 participants)	Inhaled Carbon Monoxide at 100ppm for up to 90 minutes daily for 5 days
DRUG	Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants)	Inhaled Medical Air for up to 90 minutes daily for 5 days
DRUG	Inhaled Carbon Monoxide at 200ppm (4 participants)	Inhaled Carbon Monoxide at 200ppm for 90 minutes daily for 5 days
DRUG	Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)	Inhaled Medical Air for up to 90 minutes daily for 5 days

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2015-04-24
• Last updated: 2019-10-17

Locations

4 sites across 1 country: United States