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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Prednisone Group | Active Comparator |
| |
| Intramuscular Compound Betamethasone Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in percent predicted FVC after 24 weeks of treatment (%) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Huang | Contact | 86+13391587917 | pumchhh@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012507 | Sarcoidosis |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| 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. |
|
| 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 |
| Relapse rate of sarcoidosis at 36 and 48 weeks after treatment initiation | 36 weeks and 48 weeks |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |