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

Sponsor

Actelion (Industry)

Overall Status

Completed

CT.gov ID

NCT00109681

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Fibrosis Pulmonary Hypertension	Drug: Iloprost Inhalation Solution (Ventavis)	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

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)

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Safety []

Secondary Outcome Measures

6 minute walk distance []
exercise associated oxygen desaturation []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	UCLA School of Medicine	Los Angeles	California	United States	90095
3	University of California, San Diego	San Diego	California	United States	92037
4	University of California, San Francisco	San Francisco	California	United States	94143
5	University of Miami	Miami	Florida	United States	33136
6	The University of Chicago	Chicago	Illinois	United States	60637
7	University of Iowa College of Medicine	Iowa City	Iowa	United States	52242
8	Tulane University	New Orleans	Louisiana	United States	70112
9	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
10	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
11	Mount Sinai Medical Center	New York	New York	United States	10029
12	Duke University Medical Center	Durham	North Carolina	United States	27710
13	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania	United States	15213
14	Vanderbilt University Medical	Nashville	Tennessee	United States	37232
15	Baylor College of Medicine	Houston	Texas	United States	77030
16	University of Texas Health Center at Tyler	Tyler	Texas	United States	75708
17	Inova Research Center	Church Falls	Virginia	United States	22042