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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Iloprost; Pharmaceutical Solutions

Criteria

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