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Completed

NCT Number: NCT01214187

Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

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

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhaled carbon monoxide

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.

Other names: CO

Oxygen

Other

Room air oxygen concentrations will be administered as placebo

Other names: O2

Primary outcomes

  1. Serum MMP7 Level

    Time frame: Baseline to Week 12

    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 outcomes

  1. Total Lung Capacity % Predicted Values (TLC)

    Time frame: Baseline to Week 12

    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

  2. Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values

    Time frame: Baseline to Week 12

    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

  3. Six Minute Walk Distance

    Time frame: Baseline to Week 12

    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

  4. St George's Respiratory Questionnaire

    Time frame: Baseline to Week 12

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Columbia University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Tulane University
  • University of California, San Francisco
  • University of Chicago
  • University of Illinois at Chicago
  • University of Michigan
  • University of Washington

Registry information

Official study title

Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Oct 4, 2010
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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