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

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00109681
First received: May 2, 2005
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Pulmonary Fibrosis
Pulmonary Hypertension
Drug: Iloprost Inhalation Solution (Ventavis)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • 6 minute walk distance
  • exercise associated oxygen desaturation

Estimated Enrollment: 50
Study Start Date: April 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109681

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095
University of California, San Diego
San Diego, California, United States, 92037
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa College of Medicine
Iowa City, Iowa, United States, 52242
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708
United States, Virginia
Inova Research Center
Church Falls, Virginia, United States, 22042
Sponsors and Collaborators
Actelion
Investigators
Study Director: James Pennington, MD CoTherix
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00109681     History of Changes
Other Study ID Numbers: ACTIVE C200-003
Study First Received: May 2, 2005
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
ACTIVE
iloprost
idiopathic pulmonary fibrosis
pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension
Fibrosis
Hypertension, Pulmonary
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pharmaceutical Solutions
Iloprost
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014