Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis

Phase 2

Completed

• Conditions: Pulmonary Fibrosis; Pulmonary Hypertension

• Registration Number: NCT00109681
• Lead Sponsor: Actelion

Brief Summary

The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial pressure. The secondary purpose is to evaluate the effectiveness of this treatment in subjects with this disease.

Detailed Description

While there are no FDA approved therapies for the treatment of IPF, there are therapies that have been shown to be effective in ameliorating the effects of pulmonary hypertension in patients with PAH (pulmonary arterial hypertension), including inhaled iloprost. However, these therapies have not been used extensively in patients with IPF who have pulmonary hypertension as a complication. The potential benefits of treatment of pulmonary hypertension complicating IPF include: improvement in pulmonary hemodynamics, with reduction in pulmonary artery pressure and pulmonary vascular resistance, and increase in cardiac output.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-05-02
• Study First Submitted QC: 2005-05-02
• Study First Posted: 2005-05-03
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2010-02
• Disposition First Submitted: 2010-02-11
• Disposition First Submitted QC: 2010-02-11
• Last Update Submitted: 2010-02-11
• Disposition First Posted: 2010-02-15
• Last Update Posted: 2010-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society criteria
• Diagnosis of elevated pulmonary pressures
• Six minute walk distance between 50-380
• NYHA functional class II - IV

Exclusion Criteria

• Pulmonary fibrosis related to a systemic disorder
• Significant chronic obstructive pulmonary disease
• History of thromboembolic disease within the previous year
• Awaiting lung transplantation within next 36 weeks
• Active lung infection
• Survival prognosis of less than 1 year
• Significant left-sided heart failure, active coronary artery disease
• Clinically relevant liver disease
• Concurrent medications: epoprostenol, treprostinil, bosentan, PDE-5 inhibitor, investigational agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
6 minute walk distance
exercise associated oxygen desaturation

Trial Locations

Locations (17)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Pittsburgh School of Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

University of Iowa College of Medicine; 🇺🇸 Iowa City, Iowa, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Vanderbilt University Medical; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Inova Research Center; 🇺🇸 Church Falls, Virginia, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

University of Texas Health Center at Tyler; 🇺🇸 Tyler, Texas, United States