Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
NCT ID: NCT01214187
Last Updated: 2017-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2011-07-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
Oxygen 21%
Oxygen
Room air oxygen concentrations will be administered as placebo
Interventions
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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.
Oxygen
Room air oxygen concentrations will be administered as placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of California, San Francisco
OTHER
University of Chicago
OTHER
University of Illinois at Chicago
OTHER
University of Michigan
OTHER
Columbia University
OTHER
Tulane University
OTHER
University of Washington
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Ivan O. Rosas
Overall Principle Investigator
Principal Investigators
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Rosas O Ivan, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Joe GN Garcia, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of California San Francisco
San Francisco, California, United States
University of Illinois Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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