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Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, San Francisco
University of Chicago
University of Illinois at Chicago
University of Michigan
Columbia University
Tulane University
University of Washington
Information provided by (Responsible Party):
Ivan O. Rosas, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01214187
First received: September 30, 2010
Last updated: April 17, 2014
Last verified: April 2014

September 30, 2010
April 17, 2014
July 2011
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01214187 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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 MMP7 and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • 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
  • Other: Oxygen
    Room air oxygen concentrations will be administered as placebo
    Other Name: O2
  • 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.
    Intervention: Drug: inhaled carbon monoxide
  • Placebo Comparator: Oxygen 21%
    Intervention: Other: Oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01214187
1U01HL105371, 1U01HL105371
Yes
Ivan O. Rosas, Brigham and Women's Hospital
Brigham and Women's Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of California, San Francisco
  • University of Chicago
  • University of Illinois at Chicago
  • University of Michigan
  • Columbia University
  • Tulane University
  • University of Washington
Principal Investigator: Rosas O Ivan, MD Brigham and Women's Hospital
Principal Investigator: Joe GN Garcia, MD University of Illinois at Chicago
Brigham and Women's Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP