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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoidosis, Pulmonary
• Intervention / Treatment: Drug: Prednisone; Drug: Compound betamethasone

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hui Huang; Phone Number: 86+13391587917; Email: pumchhh@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
      • Contact: Hui Huang; Phone Number: 86+13391587917; Email: pumchhh@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Prednisone Group	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.
Experimental: Intramuscular Compound Betamethasone Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in percent predicted FVC after 24 weeks of treatment (%)	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Lung Diseases, Interstitial; Hypersensitivity, Delayed; Hemic and Lymphatic Diseases; Sarcoidosis; Sarcoidosis, Pulmonary; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Prednisone
• Other Study ID Numbers: K10933

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No