ISRCTN73579020已完成2 期
Randomised placebo-controlled, double-blind, exploratory trial of Bosentan for Steroid-resistant Pulmonary Sarcoidosis: the BOSSA Study
niversity Hospital Basel (Switzerland)0 个研究点目标入组 36 人开始时间: 2010年9月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
- 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30378090
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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%)
排除标准
- •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
研究者
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