Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis

The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by destruction of normal epithelial structure, proliferation of fibroblasts, and deposition of connective-tissue matrix proteins. There are currently no effective therapies for IPF. Over the past two decades, preclinical studies of inhaled low dose carbon monoxide (CO) have shown that this biologically active diatomic gas possesses properties that would make it a viable novel therapy for IPF. CO therapy has been well tolerated in Phase I and Phase II human trials to date. This phase II study is designed to investigate whether IPF patients show evidence of decreased peripheral blood levels of matrix metalloproteinase-7 (MMP7) and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

Inclusion Criteria:

• Adults above the age of 18 and equal to or below the age of 85
• Diagnosis of IPF by biopsy or
• American Thoracic Society (ATS)/European Respiratory Society (ERS)/ Latin American Thoracic Association (ALAT) Guidelines (Am J Respir Crit Care Med Vol 183. pp 788-824,2011)
• Forced vital capacity (FVC) greater than or equal to 50% predicted, greater than or equal to one month off all medications prescribed for IPF

Exclusion Criteria:

• Evidence of active infection within the last month
• Significant obstructive respiratory defect
• Supplemental oxygen required to maintain an oxygen saturation over 88% at rest
• History of myocardial infarction within the last year, heart failure within the last 3 years or cardiac arrhythmia requiring drug therapy
• History of smoking within 4 weeks of screening
• Pregnancy or lactation
• Participation in another therapeutic clinical trial