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

Официальное название

A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis

Обзор

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

Вмешательства

• Препарат 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 durat
• Препарат 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.

Первичные конечные точки

• Change from baseline in percent predicted FVC after 24 weeks of treatment (%) [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

• Change in lymph node score as assessed by chest CT [Срок оценки: 24 weeks, 36 weeks and 48 weeks]
• Change from baseline in absolute FVC at 24 weeks of treatment (mL) [Срок оценки: 24 weeks]
• Change from baseline in percent predicted DLCO at 24 weeks of treatment (%) [Срок оценки: 24 weeks]
• Change from baseline in percent predicted FEV1 at 24 weeks of treatment (%) [Срок оценки: 24 weeks]
• Relapse rate of sarcoidosis at 24 weeks after treatment initiation [Срок оценки: 24 weeks]
• Relapse rate of sarcoidosis at 36 and 48 weeks after treatment initiation [Срок оценки: 36 weeks and 48 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union — Пекин

Идентификаторы

NCT: NCT07668895 · K10933

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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