Clinical Trial: Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS).

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). A Multicenter, Prospective, Controlled, Randomized Trial.

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Milano Bicocca

Current Primary Outcome:

  • 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. [ Time Frame: Baseline- After 3 months of treatment ]
    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
  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Secondary EFFICACY endpoint was the change from baseline in radiographic success rate after 9 month of therapy (measured by High Resolution Chest Tomography HRCT) [ Time Frame: Baseline- After 9 months of therapy ]
    The radiographic success is determined if HRCT is resolved or improved compared to the baseline after 9 months
  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Milano Bicocca

Dates:
Date Received: July 10, 2014
Date Started: March 2009
Date Completion:
Last Updated: July 24, 2014
Last Verified: July 2014