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

Primary Purpose

Pulmonary Fibrosis, Pulmonary Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iloprost Inhalation Solution (Ventavis)
Sponsored by
Actelion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring ACTIVE, iloprost, idiopathic pulmonary fibrosis, pulmonary arterial hypertension

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • UCLA School of Medicine
  • University of California, San Diego
  • University of California, San Francisco
  • University of Miami
  • The University of Chicago
  • University of Iowa College of Medicine
  • Tulane University
  • University of Michigan Health System
  • Mayo Clinic Rochester
  • Mount Sinai Medical Center
  • Duke University Medical Center
  • University of Pittsburgh School of Medicine
  • Vanderbilt University Medical
  • Baylor College of Medicine
  • University of Texas Health Center at Tyler
  • Inova Research Center

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

6 minute walk distance
exercise associated oxygen desaturation

Full Information

First Posted
May 2, 2005
Last Updated
February 11, 2010
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00109681
Brief Title
Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Pulmonary Hypertension
Keywords
ACTIVE, iloprost, idiopathic pulmonary fibrosis, pulmonary arterial hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Iloprost Inhalation Solution (Ventavis)
Primary Outcome Measure Information:
Title
Safety
Secondary Outcome Measure Information:
Title
6 minute walk distance
Title
exercise associated oxygen desaturation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Pennington, MD
Organizational Affiliation
CoTherix
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa College of Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Inova Research Center
City
Church Falls
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

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

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