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NOT YET RECRUITING
NCT07668895
PHASE2/PHASE3

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2026-07

Completion Date

2028-07

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DRUG

Prednisone

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.

DRUG

Compound betamethasone

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.

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China