ISRCTN73579020
Completed
Phase 2
Randomised placebo-controlled, double-blind, exploratory trial of Bosentan for Steroid-resistant Pulmonary Sarcoidosis: the BOSSA Study
niversity Hospital Basel (Switzerland)0 sites36 target enrollmentSeptember 27, 2010
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Sarcoidosis with pulmonary involvement
- Sponsor
- niversity Hospital Basel (Switzerland)
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
- 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30378090
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Biopsy\-proven sarcoidosis with pulmonary involvement stages II, III, (IV) according to Silzbach
- •2\. Persistant symptoms on long\-term oral corticosteroids (greater than 2 months; 5 mg prednisone or equivalent and/or other immunosuppressive agents
- •3\. Aged greater than 18 years
- •4\. Informed written consent
- •5\. Impaired exercise capacity (oxygen uptake \[VO2] peak less than 80%) or resting lung functions (forced expiratory volume in one second \[FEV1], forced vital capacity \[FVC] or diffusing capacity of the lung for carbon monoxide \[DLCO] less than 80%)
Exclusion Criteria
- •1\. Systemic illness other than sarcoidosis requiring immunosuppressive therapy
- •2\. Honey combing greater than 10% on High Resolution Computed Tomography \[HRCT] scan
- •3\. Marked disturbance of liver enzymes at baseline
- •4\. Pregnancy
- •5\. Relevant psychiatric illness or addictive disorder
- •6\. Previous or current treatment with bosentan
- •7\. Therapry with cyclosporine A
Outcomes
Primary Outcomes
Not specified
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