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| Name | Class |
|---|---|
| Agenzia Italiana del Farmaco | OTHER_GOV |
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The aim of the study is determining the non-inferiority in the overall success rate and the safety for a combination therapy with hydroxychloroquine plus low dose glucocorticoids compared to that for high dose glucocorticoids at 3 and 9 months in patients with pulmonary sarcoidosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Active Comparator | Prednisone per os 0,5 mg/kg/die once/day for 3 months. After 3 months, between responders, prednisone was slowly tapered (5 mg/week maintaining the new reduced dose for one week) to 0,2 mg/kg/die for further 6 months. |
|
| Hydroxychloroquine + Prednisone | Experimental | Hydroxychloroquine per os 200 mg/die (or adjusted for body weight if less than 61 kg), twice/day + prednisone 0,15 mg/kg per os daily, once/day for 3 months, than for further 6 months between responders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone per os 0,5 mg/kg/die once/day for 3 months. After 3 months, between responders, prednisone was slowly tapered (5 mg/week maintaining the new reduced dose for one week) to 0,2 mg/kg/die for further 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary EFFICACY measure is the per-subject overall success rate at the 3 month visit. Overall response is defined as a combined radiographic and clinical responses. | Subjects is considered clinically cured at the 3 month visit if they will have radiographic success (determined if Chest X-Ray is resolved or improved compared to the baseline; improvement was assessed if there were reduction in hilar adenopathies, less pulmonary involvement, changing in radiographic stage) PLUS a change in at least one of the followings: symptoms (determined by dyspnea or cough index score decrease compared to the baseline), and/or functional improvement (determined by an increase in % of predicted Forced Vital Capacity and/or increase in % of predicted Single-Breath Diffusion capacity of Lung for Carbon monoxide DLCO-SB compared to the baseline), and/or increase in resting Partial pressure of Oxygen in the artery blood (PaO2), and/or worst oxygen saturation increase during 6 Minute Walk Test (6MWT) and/or increase in distance walked at 6MWT, compared to the baseline | Baseline- After 3 months of treatment |
| The primary SAFETY endpoint is the percent change in lumbar spine (L1-L4) bone mineral density from baseline to month 9 as measured by Dual energy X-ray Absorptiometry (DXA) | Baseline - After 9 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary EFFICACY endpoint was the change from baseline in radiographic success rate after 9 month of therapy (measured by High Resolution Chest Tomography HRCT) | The radiographic success is determined if HRCT is resolved or improved compared to the baseline after 9 months | Baseline- After 9 months of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Pesci | Università Milano Bicocca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università degli Studi di Milano - Bicocca | Milan | Milano | 20126 | Italy |
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| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Hydroxychloroquine + Prednisone | Drug | Hydroxychloroquine per os 200 mg/die (or adjusted for body weight if less than 61 kg), twice/day + prednisone 0,15 mg/kg per os daily, once/day for 3 months, than for further 6 months between responders. |
|
| Secondary SAFETY endpoint was the change from baseline in Body Mass Index |
| Baseline - After 3, 6 and 9 months |
| Secondary SAFETY endpoint was the change from baseline in HbA1c | At 3, 6 and 9 months of therapy |
| Secondary SAFETY endpoint was the change from baseline in clinical laboratory tests (including inflammatory markers) | At 3, 6 and 9 months of therapy |
| Secondary SAFETY endpoint was the change from baseline in bone turnover markers and mineral metabolism | At months 3 and 9 from the start of therapy |
| Secondary safety endpoint was the number of participants with Serious and Non-Serious Adverse Events | Within the 9 months of therapy |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |