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

Phase 3Not Yet RecruitingNCT07668895

Peking Union Medical College Hospital126 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Sarcoidosis, Pulmonary

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 24 weeks

Secondary Outcomes

Change in lymph node score as assessed by chest CT

Time frame: 24 weeks, 36 weeks and 48 weeks

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

Time frame: 24 weeks

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

Time frame: 24 weeks

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

Time frame: 24 weeks

Relapse rate of sarcoidosis at 24 weeks after treatment initiation

Time frame: 24 weeks

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

Time frame: 36 weeks and 48 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts