Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: inhaled carbon monoxide; Other: Oxygen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01214187

1U01HL105371 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

carbon monoxide inhalation

Experimental group

Description:

The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.

Treatment:

Drug: inhaled carbon monoxide

Oxygen 21%

Placebo Comparator group

Treatment:

Other: Oxygen