Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
Key facts
- Phase
- Phase 2/3
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT07668895, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07668895
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
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
Inclusion: 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.
Exclusion: Patient or family members are unable to understand the conditions and objectives of this study, or are unable to provide informed consent; Presence of other serious diseases that, in the investigator's judgment, may affect patient safety or compliance; Active malignancy requiring treatment (surgery, medical therapy, or radiotherapy); Hypersensitivity to Diprospan (Compound Betamethasone) or prednisone; Any significant clinical or laboratory abnormalities that, in the investigator's judgment, may affect safety evaluation; Subjects who cannot comply with the follow-up schedule as required by the protocol; Pregnant or breastfeeding women, or patients who cannot use effective contraception during the study period and within 3 months after the study ends.