Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

NCT ID: NCT01214187

Last Updated: 2017-06-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Group Type EXPERIMENTAL

inhaled carbon monoxide

Intervention Type DRUG

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%

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type OTHER

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.

Intervention Type DRUG

Oxygen

Room air oxygen concentrations will be administered as placebo

Intervention Type OTHER

Other Intervention Names

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CO O2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Tulane University

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ivan O. Rosas

Overall Principle Investigator

Responsibility Role PRINCIPAL_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

Site Status

University of Illinois Chicago

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 29100885 (View on PubMed)

Other Identifiers

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1U01HL105371

Identifier Type: NIH

Identifier Source: secondary_id

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1U01HL105371

Identifier Type: NIH

Identifier Source: org_study_id

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