Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis
1 other identifier
interventional
58
1 country
8
Brief Summary
The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2011
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2010
CompletedFirst Posted
Study publicly available on registry
October 4, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
May 1, 2017
3.3 years
September 30, 2010
March 1, 2017
May 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Week 12
Secondary Outcomes (4)
Total Lung Capacity % Predicted Values (TLC)
Baseline to Week 12
Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values
Baseline to Week 12
Six Minute Walk Distance
Baseline to Week 12
St George's Respiratory Questionnaire
Baseline to Week 12
Study Arms (2)
carbon monoxide inhalation
EXPERIMENTALThe 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.
Oxygen 21%
PLACEBO COMPARATORInterventions
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.
Room air oxygen concentrations will be administered as placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of California, San Franciscocollaborator
- University of Chicagocollaborator
- University of Illinois at Chicagocollaborator
- University of Michigancollaborator
- Columbia Universitycollaborator
- Tulane Universitycollaborator
- University of Washingtoncollaborator
Study Sites (8)
University of California San Francisco
San Francisco, California, 94143, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Columbia University
New York, New York, 10032, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 29100885DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ivan Rosas, MD
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Rosas O Ivan, MD
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
Joe GN Garcia, MD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Overall Principle Investigator
Study Record Dates
First Submitted
September 30, 2010
First Posted
October 4, 2010
Study Start
July 1, 2011
Primary Completion
October 1, 2014
Study Completion
April 1, 2015
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-05