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

February 11, 2010 updated by: Actelion

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety

Secondary Outcome Measures

Outcome Measure
6 minute walk distance
exercise associated oxygen desaturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: James Pennington, MD, CoTherix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

May 2, 2005

First Submitted That Met QC Criteria

May 2, 2005

First Posted (ESTIMATE)

May 3, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIVE C200-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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