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

NCT07668895 | Not Yet Recruiting Phase 2

• 1 other identifier: K10933
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sarcoidosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Oral Prednisone Group

ACTIVE COMPARATOR

Drug: Prednisone

Intramuscular Compound Betamethasone Group

EXPERIMENTAL

Drug: Compound betamethasone

Interventions

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.

Oral Prednisone Group

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.

Intramuscular Compound Betamethasone Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Hui Huang

CONTACT

86+13391587917; pumchhh@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

CN (1)