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

Pulmonary Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109681
• Other study ID #: ACTIVE C200-003
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2005
• Last updated: February 11, 2010
• Start date: April 2005
• Est. completion date: October 2006

Study information

• Verified date: February 2010
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hypertension, Pulmonary
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis
• Pulmonary Hypertension

Intervention

Drug:
• Iloprost Inhalation Solution (Ventavis)

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	The University of Chicago	Chicago	Illinois
United States	Inova Research Center	Church Falls	Virginia
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa College of Medicine	Iowa City	Iowa
United States	UCLA School of Medicine	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Vanderbilt University Medical	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	University of Texas Health Center at Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Secondary	6 minute walk distance
Secondary	exercise associated oxygen desaturation