Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01214187
• Other study ID #: 1U01HL105371
• Secondary ID: 1U01HL105371
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 30, 2010
• Last updated: May 11, 2015
• Start date: July 2011
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 MMP7 and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adults above the age of 18 and equal to or below the age of 85

• Diagnosis of IPF by biopsy or

• ATS/ERS/ALAT Guidelines (Am J Respir Crit Care Med Vol 183. pp 788-824,2011)

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Other:
• Oxygen
Room air oxygen concentrations will be administered as placebo

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois Chicago	Chicago	Illinois
United States	Tulane University	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	University of California San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (9)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Columbia University, National Heart, Lung, and Blood Institute (NHLBI), Tulane University, University of California, San Francisco, University of Chicago, University of Illinois at Chicago, University of Michigan, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum MMP7 level	Our primary outcome is the change in MMP7 serum level over 3 months of treatment. Serum MMP7 concentrations in peripheral blood are easily measureable and reflect changes in the alveolar microenvironment. Thus, we have chosen to study mean serum MMP7 concentrations after three months of CO treatment as a surrogate biomarker of the effect of inhaled CO administration on disease progression.	3 months	No
Secondary	Total lung capacity (TLC)	Total lung capacity (TLC) is a major clinical determinant of restrictive lung disease in practice, with TLC measurement below the 5th percentile of the predicted value indicative of a restrictive ventilatory defect	3 months	No
Secondary	Diffusing capacity for carbon monoxide	Interstitial changes associated with IPF can worsen diffusing capabilities across the alveolar-capillary membrane. As a result, diffusing capacity of carbon monoxide is an important outcome to assess architectural distortion and resultant decrements in diffusing capabilities	3 months	No
Secondary	Six minute walk distance	The six minute walk distance is commonly used both in research studies and in clinical practice as a measure of functional capabilities, and changes in six minute walk distance and oxygen use during testing over time often reflect clinically relevant disease progression. We will measure the distance travelled during six minutes (meters) in accordance with published guidelines	3 months	No
Secondary	St George's Respiratory Questionnaire	St. George's Respiratory Questionnaire (SGRQ) is a validated self-reported instrument. In this instrument, scores range from 0 to 100, with higher scores reflective of worse quality of life.	3 months	No