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Not yet recruitingNCT07668895Updated Jun 25, 2026

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

A Phase 2/3 interventional study of Prednisone and Compound betamethasone in Sarcoidosis, Pulmonary, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Peking Union Medical College Hospital · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

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
02

Conditions studied

  • Sarcoidosis, Pulmonary

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03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • Active comparator
    Oral Prednisone Group

    Drug: Prednisone

  • Experimental
    Intramuscular Compound Betamethasone Group

    Drug: Compound betamethasone

Interventions

  • DrugPrednisone

    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.

  • DrugCompound 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.

05

What researchers measure

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

  1. Change in lymph node score as assessed by chest CT

    Time frame: 24 weeks, 36 weeks and 48 weeks

  2. Change from baseline in absolute FVC at 24 weeks of treatment (mL)

    Time frame: 24 weeks

  3. Change from baseline in percent predicted DLCO at 24 weeks of treatment (%)

    Time frame: 24 weeks

  4. Change from baseline in percent predicted FEV1 at 24 weeks of treatment (%)

    Time frame: 24 weeks

  5. Relapse rate of sarcoidosis at 24 weeks after treatment initiation

    Time frame: 24 weeks

  6. Relapse rate of sarcoidosis at 36 and 48 weeks after treatment initiation

    Time frame: 36 weeks and 48 weeks

06

Study locations

1 site
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
    Beijing, Beijing Municipality 100730, China
07

Registry details

Key details

Study ID
NCT07668895
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Jun 25, 2026

Study contacts

Hui Huang
Contact
pumchhh@126.com
86+13391587917

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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