Safety and Efficacy Study of Bosentan in Progressive Pulmonary Sarcoidosis (BOPSAC)
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|ClinicalTrials.gov Identifier: NCT00926627|
Recruitment Status : Terminated (Not enough patients with the specified criteria could not)
First Posted : June 23, 2009
Last Update Posted : September 15, 2016
Progressive pulmonary sarcoidosis occurs in up to twenty percent of patients who require persistent treatment, but available treatment options have shown considerable long-term toxicity and uncertain or unproven efficacy. In these patients, pulmonary fibrosis and pulmonary hypertension are common complications which have major prognostic impact. Endothelin-1 (ET-1) has been demonstrated to play a key role in pulmonary fibrosis and pulmonary hypertension, and a potential role in pulmonary sarcoidosis. ET-1 is a potent vasoconstrictor and can promote fibrosis, cell proliferation, and remodeling, and is pro-inflammatory. Preliminary data have shown the therapeutic potential of the endothelin receptor antagonist (ERA) bosentan in sarcoidosis associated pulmonary hypertension.
In this light, the therapeutic potential of bosentan as an add-on treatment in progressive pulmonary sarcoidosis needs to be evaluated.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis Pulmonary Hypertension||Drug: bosentan Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Randomized, Double Blind, Placebo-controlled, Safety and Efficacy Study of Bosentan as add-on Therapy in Progressive Pulmonary Sarcoidosis|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Placebo Comparator: Placebo
identical preparation as the study drug, but without the active substance, administered b.i.d.
62.5 mg/125 mg bosentan b.i.d.
62.5 mg tablets b.i.d. administered orally for 4 weeks followed by the maintenance dose of 125 mg b.i.d. (62.5 mg b.i.d. if body weight < 40 kg/90 lb)
- Treatment efficacy is assessed by a composite clinical score, including six parameters: Pulmonary function test (FVC and DLCO), Blood gas analysis (AaDO2), HRCT (Oberstein score), 6 minute walk test (6-MWD), Dyspnoea (ATS dyspnea scale) [ Time Frame: 6 months ]
- Assess safety and tolerability of bosentan in progressive pulmonary sarcoidosis [ Time Frame: 6 months ]
- To evaluate the efficacy of bosentan treatment in the subgroups of patents with and without sarcoidosis-associated pulmonary hypertension. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926627
|General Hospital Vienna|
|Vienna, Austria, 1090|
|Vienna, Austria, 1180|
|Study Director:||Daniel Doberer, MD, MSc||Medical University of Vienna|