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

NCT ID: NCT00109681

Last Updated: 2010-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Fibrosis Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Iloprost Inhalation Solution (Ventavis)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Principal Investigators

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James Pennington, MD

Role: STUDY_DIRECTOR

CoTherix

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

The University of Chicago

Chicago, Illinois, United States

Site Status

University of Iowa College of Medicine

Iowa City, Iowa, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt University Medical

Nashville, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Texas Health Center at Tyler

Tyler, Texas, United States

Site Status

Inova Research Center

Church Falls, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ACTIVE C200-003

Identifier Type: -

Identifier Source: org_study_id

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