跳至主要内容
临床试验/NCT07668895
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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年7月1日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Evaluation of the Efficacy and Safety of Compound... | 临床试验