A Phase 3 interventional study of Prednisone and Hydroxychloroquine + Prednisone in Pulmonary Sarcoidosis, sponsored by University of Milano Bicocca. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-25.
Sponsored by University of Milano Bicocca · Phase 3, Interventional, and Treatment
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.
63 studies on the registry are indexed under Sarcoidosis, Pulmonary; 15 are open to participants now.
This study's enrollment of 94 is above the median of 53 across 48 interventional studies indexed under Sarcoidosis, Pulmonary.
Browse Sarcoidosis, Pulmonary studies →University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Prednisone
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.
Drug: Hydroxychloroquine + Prednisone
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 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.
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
Time frame: 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)
Time frame: Baseline - After 9 months of treatment
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
Time frame: Baseline- After 9 months of therapy
Secondary SAFETY endpoint was the change from baseline in Body Mass Index
Time frame: Baseline - After 3, 6 and 9 months
Secondary SAFETY endpoint was the change from baseline in HbA1c
Time frame: At 3, 6 and 9 months of therapy
Secondary SAFETY endpoint was the change from baseline in clinical laboratory tests (including inflammatory markers)
Time frame: At 3, 6 and 9 months of therapy
Secondary SAFETY endpoint was the change from baseline in bone turnover markers and mineral metabolism
Time frame: 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
Time frame: Within the 9 months of therapy
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University of Milano Bicocca