Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis

NCT07668895 — Phase 2 / Phase 3, Not yet recruiting, 126 participants, Peking Union Medical College Hospital

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A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis

Registry	NCT07668895
Status	Not yet recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	126 (Estimated)
Sponsor	Peking Union Medical College Hospital (Other)
Conditions	Sarcoidosis, Pulmonary
Interventions	Prednisone, Compound betamethasone (Drug)
Dates	start 2026-11-01 (estimated), primary completion 2027-07-01 (estimated), completion 2028-07-01 (estimated), first posted 2026-06-25, last updated 2026-10-15
Locations	1 site in China

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Oral Prednisone Group	Active comparator	Drug: Prednisone
Intramuscular Compound Betamethasone Group	Experimental	Drug: Compound betamethasone

Prednisone (Drug): Prednisone, oral administration. Starting dose of 40 mg once daily for 2 weeks, followed by gradual tapering according to the following schedule: reduce by half a tablet (2.5 mg) each week. When the dose is reduced to 1 tablet (5 mg) once daily, maintain for 2 weeks; then reduce to half a tablet (2.5 mg) once daily for 2 weeks; then reduce to half a tablet (2.5 mg) every other day for 2 weeks; then reduce to half a tablet (2.5 mg) twice weekly for 2 weeks, then discontinue. Total treatment duration is 24 weeks.
Compound betamethasone (Drug): Compound Betamethasone injection, administered intramuscularly. Each injection is 1 mL, given once every 4 weeks for a total of 6 injections, with a treatment period of 24 weeks.

+Outcome measures

Primary outcomes

Change from baseline in percent predicted FVC after 24 weeks of treatment (%) [24 weeks]

Secondary outcomes

Change in lymph node score as assessed by chest CT [24 weeks, 36 weeks and 48 weeks]
Change from baseline in absolute FVC at 24 weeks of treatment (mL) [24 weeks]
Change from baseline in percent predicted DLCO at 24 weeks of treatment (%) [24 weeks]
Change from baseline in percent predicted FEV1 at 24 weeks of treatment (%) [24 weeks]
Relapse rate of sarcoidosis at 24 weeks after treatment initiation [24 weeks]
Relapse rate of sarcoidosis at 36 and 48 weeks after treatment initiation [36 weeks and 48 weeks]

+Eligibility

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

* 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 Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing, Beijing Municipality	China