Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF)
1 other identifier
interventional
50
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2005
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 2, 2005
CompletedFirst Posted
Study publicly available on registry
May 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFebruary 15, 2010
February 1, 2010
1.5 years
May 2, 2005
February 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Secondary Outcomes (2)
6 minute walk distance
exercise associated oxygen desaturation
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
University of California, San Diego
San Diego, California, 92037, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33136, United States
The University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa College of Medicine
Iowa City, Iowa, 52242, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Center at Tyler
Tyler, Texas, 75708, United States
Inova Research Center
Church Falls, Virginia, 22042, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Pennington, MD
CoTherix
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2005
First Posted
May 3, 2005
Study Start
April 1, 2005
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
February 15, 2010
Record last verified: 2010-02