Status:
COMPLETED
Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Actelion
Conditions:
Pulmonary Fibrosis
Pulmonary Hypertension
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
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 second...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00109681
Start Date
April 1 2005
End Date
October 1 2006
Last Update
February 15 2010
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UCLA School of Medicine
Los Angeles, California, United States, 90095
3
University of California, San Diego
San Diego, California, United States, 92037
4
University of California, San Francisco
San Francisco, California, United States, 94143