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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00581607
• Date of registration: 26/12/2007
• Prospective Registration: Yes
• Primary sponsor: University of Cincinnati
• Public title: Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension BOSAPAH
• Scientific title: Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
• Date of first enrolment: April 2008
• Target sample size: 43
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00581607
• 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
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Robert P Baughman, MD
• Affiliation: University of Cincinnati

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcoidosis

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Bosentan

Drug: Placebo

Primary Outcome(s)

Improvement in six minute walk distance [Time Frame: 16 weeks]

Secondary Outcome(s)

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]

Secondary ID(s)

7-3-22-1

BOSAPAH-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Actelion