Steroid Treatment Effect in Pulmonary Sarcoidosis - STEPS

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- Patients with stage II/III (based on a chest X-ray or equivalent on a CT-scan) sarcoidosis (established using the criteria of the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG));
•- A FVC * 80% of predicted AND/OR an absolute decline of *10% predicted FVC within 12 months;
•- A pulmonary indication for prednisolone treatment (determined by the treating physician and conform current clinical guidelines) ;
•- Written informed consent;
•- Age > 18.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•- Previous immunosuppressive treatment for sarcoidosis (e.g. prednisone, methotrexate (MTX), Infliximab);
•- Use of systemic immunosuppressive therapy within the previous 3 months for another disease then sarcoidosis;
•- Contra-indication for steroids;
•- Other conditions which could influence pulmonary function, such as:
•o Concurrent chronic obstructive pulmonary disorder (COPD);
•o Concurrent active asthma (according to GINA guidelines);
•o Fibrotic lung disease;
•o Pregnancy;
•o Morbide obesitas (BMI > 30);
•- Pulmonary malignancies.

发起方