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

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension; Ayerza Syndrome; Pulmonary Hypertension

Intervention: Iloprost or placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Henry Hsu, M.D., Study Director, Affiliation: CoTherix


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).

Clinical Details

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

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

Detailed 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.


Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year)


- 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

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

UCSD Medical Center, La Jolla, California 92037, United States

Stanford University Medical Center, Palo Alto, California 94305, United States

UCSF Medical Center, San Francisco, California 94143, United States

Harbor-UCLA Medical Center, Torrance, California 90502, United States

The Children's Hospital, Denver, Colorado 80218, United States

University of Colorado HSC, Denver, Colorado 80262, United States

Rush Heart Institute, Center for Pulmonary Heart Disease, Chicago, Illinois 60612, United States

Johns Hopkins University, Baltimore, Maryland 21205, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

Mayo Clinic, Rochester, Minnesota 55095, United States

Columbia University Medical Center, New York, New York 10032, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Latter Day Saints Hospital, Salt Lake City, Utah 84143, United States

Additional Information

Related publications:

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.

Starting date: June 2004
Last updated: March 31, 2011

Page last updated: August 23, 2015

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