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

NCT00581607 | Completed Phase 2 DMC

• 2 other identifiers: BOSAPAH-17-3-22-1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

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.

Conditions

Sarcoidosis; Pulmonary Arterial Hypertension

Keywords

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Improvement in six minute walk distance

  16 weeks

Secondary Outcomes (3)

• Change in pulmonary hemodynamics

  16 weeks

• Improvement in quality of life with therapy

  48 weeks

• Safety of treatment

  48 weeks

Study Arms (2)

Bosentan for 16 weeks

ACTIVE COMPARATOR

Active drug

Drug: Bosentan

Placebo

PLACEBO COMPARATOR

Placebo for 16 weeks

Drug: Placebo

Interventions

Bosentan DRUG

62.5 mg bid for 4 weeks, then 125 mg bid

Also known as: Tracleer

Bosentan for 16 weeks

Placebo DRUG

Placebo twice a day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• Actelion: collaborator

Study Sites (4)

Mount Sinai

New York, New York, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Related Publications (1)

• 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.

  PMID: 24177203 DERIVED

MeSH Terms

Conditions

Sarcoidosis; Pulmonary Arterial Hypertension

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert P Baughman, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: December 27, 2007
• Study Start: April 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

US (4)