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

December 26, 2007
April 10, 2013
April 2008
October 2012   (final data collection date for primary outcome measure)
Improvement in six minute walk distance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581607 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Sarcoidosis
  • Pulmonary Arterial Hypertension
  • Drug: Bosentan
    62.5 mg bid for 4 weeks, then 125 mg bid
    Other Name: Tracleer
  • Drug: Placebo
    Placebo twice a day
  • Drug: Bosentan
    drug given for 16 weeks
    Other Name: tracleer
  • Drug: Placebo
    placebo
  • Active Comparator: Bosentan for 16 weeks
    Active drug
    Interventions:
    • Drug: Bosentan
    • Drug: Bosentan
  • Placebo Comparator: Placebo
    Placebo for 16 weeks
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
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):810-7. doi: 10.1378/chest.13-1766.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581607
BOSAPAH-1, 7-3-22-1
Yes
Robert P Baughman, University of Cincinnati
University of Cincinnati
Actelion
Principal Investigator: Robert P Baughman, MD University of Cincinnati
University of Cincinnati
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP