BOSSA Study: Bosentan for the treatment of Steroid-resistant Pulmonary Sarcoidosis

Phase 2

Completed

• Conditions: Sarcoidosis with pulmonary involvement; Haematological Disorders; Sarcoidosis

• Registration Number: ISRCTN73579020
• Lead Sponsor: niversity Hospital Basel (Switzerland)

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30378090

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-27
• Study Completion: 2012-12-31
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified