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Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
inhaled carbon monoxide
Oxygen
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis, carbon monoxide

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California San Francisco
  • University of Illinois Chicago
  • University of Chicago
  • Tulane University
  • Brigham and Women's Hospital
  • University of Michigan
  • Columbia University
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

carbon monoxide inhalation

Oxygen 21%

Arm 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.

Outcomes

Primary Outcome Measures

Serum MMP7 Level
The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. 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 % Predicted Values (TLC)
Total lung capacity % predicted values (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 (DLCO) % Predicted Values
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
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
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.

Full Information

First Posted
September 30, 2010
Last Updated
May 18, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT01214187
Brief Title
Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
Official Title
Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.
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 matrix metalloproteinase-7 (MMP7) and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis, carbon monoxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carbon monoxide inhalation
Arm Type
Experimental
Arm 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.
Arm Title
Oxygen 21%
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
inhaled carbon monoxide
Other Intervention Name(s)
CO
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oxygen
Other Intervention Name(s)
O2
Intervention Description
Room air oxygen concentrations will be administered as placebo
Primary Outcome Measure Information:
Title
Serum MMP7 Level
Description
The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. 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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Total Lung Capacity % Predicted Values (TLC)
Description
Total lung capacity % predicted values (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
Time Frame
Baseline to Week 12
Title
Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values
Description
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
Time Frame
Baseline to Week 12
Title
Six Minute Walk Distance
Description
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
Time Frame
Baseline to Week 12
Title
St George's Respiratory Questionnaire
Description
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.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosas O Ivan, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joe GN Garcia, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29100885
Citation
Rosas IO, Goldberg HJ, Collard HR, El-Chemaly S, Flaherty K, Hunninghake GM, Lasky JA, Lederer DJ, Machado R, Martinez FJ, Maurer R, Teller D, Noth I, Peters E, Raghu G, Garcia JGN, Choi AMK. A Phase II Clinical Trial of Low-Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis. Chest. 2018 Jan;153(1):94-104. doi: 10.1016/j.chest.2017.09.052. Epub 2017 Oct 31.
Results Reference
derived

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Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

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