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

Completed · Phase 2

Conditions studied: Pulmonary Fibrosis, Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT00109681

Run by

Actelion

People needed

50

Starts

2005-04-01

Expected to finish

2006-10-01

Last updated by the study team

2010-02-15

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UCLA School of Medicine — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• The University of Chicago — Chicago, Illinois, United States
• University of Iowa College of Medicine — Iowa City, Iowa, United States
• Tulane University — New Orleans, Louisiana, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Center at Tyler — Tyler, Texas, United States
• Inova Research Center — Church Falls, Virginia, United States

Full record on ClinicalTrials.gov

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