Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

This study is currently recruiting participants.
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Collaborators:
University of California, San Francisco
University of Chicago
University of Illinois at Chicago
University of Michigan
Information provided by (Responsible Party):
Augustine Choi, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01214187
First received: September 30, 2010
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: inhaled carbon monoxide
Other: Oxygen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Serum MMP7 level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Total lung capacity (TLC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Diffusing capacity for carbon monoxide [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • Six minute walk distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • St George's Respiratory Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carbon monoxide inhalation
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.
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 Name: CO
Placebo Comparator: Oxygen 21% Other: Oxygen
Room air oxygen concentrations will be administered as placebo
Other Name: O2

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01214187

Contacts
Contact: Betsy Peters, BSN. RN 617-525-9331 epeters2@partners.org

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Archer Eller    415-353-2060      
Principal Investigator: Collard Hal, MD         
United States, Illinois
University of Illinois Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Nancy Cassanova    312-355-5934      
Principal Investigator: Roberto Machado, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Spring Holland    773-834-4053      
Principal Investigator: Noth Imre, MD         
United States, Louisiana
Tulane University Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sandy Ditta    504-988-4040      
Principal Investigator: Lasky Joseph, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Choi MK Augustine, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Deb Dalgren    734-232-6303      
Principal Investigator: Fernando J Martinez, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Jaya Tiwari    212-342-1518      
Principal Investigator: David Lederer, MD         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Carolyn Spada    206-598-4967      
Principal Investigator: Ganesh Raghu, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
University of California, San Francisco
University of Chicago
University of Illinois at Chicago
University of Michigan
Investigators
Principal Investigator: Augustine MK Choi, MD Brigham and Women's Hospital
Principal Investigator: Joe GN Garcia, MD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Augustine Choi, Overall Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01214187     History of Changes
Other Study ID Numbers: 1U01HL105371, 1U01HL105371
Study First Received: September 30, 2010
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
idiopathic pulmonary fibrosis
IPF
pulmonary fibrosis
carbon monoxide

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014