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

NCT07668895 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-06-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-07-31
Completion
2028-07-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668895 on ClinicalTrials.gov