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

Sponsor

University of Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT00581607

Collaborator

Actelion (Industry)

Enrollment

Locations

Arms

Duration (Months)

10.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis Pulmonary Arterial Hypertension	Drug: Bosentan Drug: Placebo Drug: Bosentan Drug: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bosentan for 16 weeks Active drug	Drug: Bosentan 62.5 mg bid for 4 weeks, then 125 mg bid Other Names: Tracleer Drug: Bosentan drug given for 16 weeks Other Names: tracleer
Placebo Comparator: Placebo Placebo for 16 weeks	Drug: Placebo Placebo twice a day Drug: Placebo placebo

Arm

Intervention/Treatment

Active Comparator: Bosentan for 16 weeks

Active drug

Drug: Bosentan

62.5 mg bid for 4 weeks, then 125 mg bid

Other Names:

Tracleer

Drug: Bosentan

drug given for 16 weeks

Other Names:

tracleer

Placebo Comparator: Placebo

Placebo for 16 weeks

Drug: Placebo

Placebo twice a day

Drug: Placebo

placebo

Outcome Measures

Primary Outcome Measures

Improvement in six minute walk distance [16 weeks]

Secondary Outcome Measures

Change in pulmonary hemodynamics [16 weeks]
Improvement in quality of life with therapy [48 weeks]
Safety of treatment [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai	New York	New York	United States
2	University of Cincinnati	Cincinnati	Ohio	United States	45267
3	Cleveland Clinic	Cleveland	Ohio	United States
4	University of Pittsburgh	Pittsburgh	Pennsylvania	United States