NCT07668895尚未招募2 期
A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn whether a study drug called Compound Betamethasone (also known as Diprospan) works to treat pulmonary sarcoidosis in people with early-stage disease (stage I or II). It will also learn about its safety compared to the standard treatment, prednisone.
The main questions it aims to answer are:
- How much does the study drug improve lung function (measured by a test called FVC%) after 24 weeks of treatment?
- How does it compare to prednisone in controlling symptoms, reducing chest lymph node swelling, and preventing relapse? Researchers will compare Compound Betamethasone injections (given once every 4 weeks) to prednisone pills (taken daily with a gradual dose reduction).
Participants will:
- Receive either the study drug injection or prednisone pills for 24 weeks
- Visit the clinic for checkups and lung function tests at weeks 6, 12, and 24
- Have chest CT scans and blood tests to monitor their condition and any side effects
- Be followed up for additional 24 weeks (up to week 48) to see if the disease comes back after treatment stops
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosed within the past 3 months with stage I-II (based on chest CT) treatment-naive pulmonary sarcoidosis, meeting the following: A. Histopathological diagnosis of sarcoidosis via tissue biopsy (bronchial mucosa, intrathoracic lymph nodes, lung, pleura, etc.) obtained during bronchoscopy; B. Chest HRCT showing mediastinal and hilar lymphadenopathy, with or without pulmonary infiltrates (nodules, patchy opacities, ground-glass opacities, etc.); C. CT stage confirmed independently by at least two experts in the field (among three experts reviewing the chest HRCT images).
- •Requiring systemic glucocorticoid therapy.
- •Able to complete scheduled follow-up visits.
- •Patient and family members understand the study protocol, are willing to participate in this study, and are able to provide written informed consent.
排除标准
- •Patient or family members are unable to understand the conditions and objectives of this study, or are unable to provide informed consent.
- •Subjects who cannot comply with the follow-up schedule as required by the protocol.
- •Presence of other serious diseases that, in the investigator's judgment, may affect patient safety or compliance.
- •Any significant clinical or laboratory abnormalities that, in the investigator's judgment, may affect safety evaluation.
- •Pregnant or breastfeeding women, or patients who cannot use effective contraception during the study period and within 3 months after the study ends.
- •Active malignancy requiring treatment (surgery, medical therapy, or radiotherapy).
- •Hypersensitivity to Diprospan (Compound Betamethasone) or prednisone.
研究者
研究点 (1)
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