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

This study has been completed.
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00581607
First received: December 26, 2007
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Sarcoidosis
Pulmonary Arterial Hypertension
 Drug: Bosentan
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

Resource links provided by NLM:

Drug Information available for: Bosentan
U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Improvement in six minute walk distance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pulmonary hemodynamics [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Improvement in quality of life with therapy [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Safety of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: April 2008
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581607

Locations
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
Actelion
Investigators
Principal Investigator: Robert P Baughman, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00581607     History of Changes
Other Study ID Numbers: BOSAPAH-1, 7-3-22-1
Study First Received: December 26, 2007
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Sarcoidosis

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Sarcoidosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Lymphoproliferative Disorders
Lymphatic Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013