Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)

Pulmonary Hypertension Clinical Trial

Official title:

A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086463
• Other study ID #: STEP STUDY
• Secondary ID: STEPPulmonary Hy
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2004
• Last updated: March 31, 2011
• Start date: June 2004
• Est. completion date: January 2006

Study information

• Verified date: March 2011
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).

Description:

This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (= 1 year) ASD, VSD, or PDA

• NYHA Functional Class III or IV

• On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks

• Age 12-75 years, of either gender

• Six minute walk distance 100-425 meters at Baseline

Exclusion Criteria:

• Any new long-term treatment for PAH added within the last 4 weeks

• Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin, concurrently, or within the last 4 weeks

• PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA

Study Design

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

Related Conditions & MeSH terms

• Ayerza Syndrome
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Intervention

Drug:
• Iloprost or placebo

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Rush Heart Institute, Center for Pulmonary Heart Disease	Chicago	Illinois
United States	The Children's Hospital	Denver	Colorado
United States	University of Colorado HSC	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	UCSD Medical Center	La Jolla	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	UCSF Medical Center	San Francisco	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

References & Publications (1)

Olschewski H, Simonneau G, Galiè N, Higenbottam T, Naeije R, Rubin LJ, Nikkho S, Speich R, Hoeper MM, Behr J, Winkler J, Sitbon O, Popov W, Ghofrani HA, Manes A, Kiely DG, Ewert R, Meyer A, Corris PA, Delcroix M, Gomez-Sanchez M, Siedentop H, Seeger W; Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 2002 Aug 1;347(5):322-9. — View Citation