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

Primary Purpose

Sarcoidosis, Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bosentan
Placebo
Bosentan
Placebo
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai
  • University of Cincinnati
  • Cleveland Clinic
  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bosentan for 16 weeks

Placebo

Arm Description

Active drug

Placebo for 16 weeks

Outcomes

Primary Outcome Measures

Improvement in six minute walk distance

Secondary Outcome Measures

Change in pulmonary hemodynamics
Improvement in quality of life with therapy
Safety of treatment

Full Information

First Posted
December 26, 2007
Last Updated
April 10, 2013
Sponsor
University of Cincinnati
Collaborators
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00581607
Brief Title
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
Acronym
BOSAPAH
Official Title
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Actelion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Pulmonary Arterial Hypertension
Keywords
Sarcoidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bosentan for 16 weeks
Arm Type
Active Comparator
Arm Description
Active drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
Tracleer
Intervention Description
62.5 mg bid for 4 weeks, then 125 mg bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo twice a day
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
tracleer
Intervention Description
drug given for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Improvement in six minute walk distance
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in pulmonary hemodynamics
Time Frame
16 weeks
Title
Improvement in quality of life with therapy
Time Frame
48 weeks
Title
Safety of treatment
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Baughman, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai
City
New York
State/Province
New York
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24177203
Citation
Baughman RP, Culver DA, Cordova FC, Padilla M, Gibson KF, Lower EE, Engel PJ. Bosentan for sarcoidosis-associated pulmonary hypertension: a double-blind placebo controlled randomized trial. Chest. 2014 Apr;145(4):810-817. doi: 10.1378/chest.13-1766.
Results Reference
derived

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

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