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Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension (BOSAPAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581607
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Brief Summary:
Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.

Condition or disease Intervention/treatment Phase
Sarcoidosis Pulmonary Arterial Hypertension Drug: Bosentan Drug: Placebo Phase 2 Phase 3

Detailed Description:
Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
Study Start Date : April 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: Bosentan for 16 weeks
Active drug
Drug: Bosentan
62.5 mg bid for 4 weeks, then 125 mg bid
Other Name: Tracleer

Drug: Bosentan
drug given for 16 weeks
Other Name: tracleer

Placebo Comparator: Placebo
Placebo for 16 weeks
Drug: Placebo
Placebo twice a day

Drug: Placebo

Primary Outcome Measures :
  1. Improvement in six minute walk distance [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change in pulmonary hemodynamics [ Time Frame: 16 weeks ]
  2. Improvement in quality of life with therapy [ Time Frame: 48 weeks ]
  3. Safety of treatment [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with known sarcoidosis 21.
  • Age 18 or greater
  • Patients with documented pulmonary hypertension with a PA mean > 25 mm Hg as measured by cardiac catheterization within six months of entry into the study. Pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm Hg.
  • Patients with WHO class II or III
  • Six minute walk distance of between 100 to 500 meters
  • Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
  • Patients able to provide written consent

Exclusion Criteria:

  • Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
  • Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
  • Patients with World Health Organization (WHO) class IV status.
  • Patients who are pregnant or breast feeding
  • Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
  • Cardiac index < 2.0 liters and/or right atrial pressure >15 mm Hg
  • Significant liver dysfunction not due to sarcoidosis.
  • Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
  • Patients unable to perform the 6 minute walk study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581607

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United States, New York
Mount Sinai
New York, New York, United States
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic
Cleveland, Ohio, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
University of Cincinnati
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Principal Investigator: Robert P Baughman, MD University of Cincinnati
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati Identifier: NCT00581607    
Other Study ID Numbers: BOSAPAH-1
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013
Keywords provided by Robert P Baughman, University of Cincinnati:
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action