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

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ClinicalTrials.gov Identifier: NCT00581607
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : April 12, 2013
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE December 27, 2007
Last Update Posted Date April 12, 2013
Study Start Date  ICMJE April 2008
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
Improvement in six minute walk distance [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
  • Change in pulmonary hemodynamics [ Time Frame: 16 weeks ]
  • Improvement in quality of life with therapy [ Time Frame: 48 weeks ]
  • Safety of treatment [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
Official Title  ICMJE Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcoidosis
  • Pulmonary Arterial Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2013)
43
Original Estimated Enrollment  ICMJE
 (submitted: December 26, 2007)
60
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581607
Other Study ID Numbers  ICMJE BOSAPAH-1
7-3-22-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert P Baughman, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Actelion
Investigators  ICMJE
Principal Investigator: Robert P Baughman, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date April 2013

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