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

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

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.

Inclusion Criteria:

• patients between 18 and 70 years
• parenchymal pulmonary involvement at Chest X-Ray (CXR) AND one of the follows: physiologic abnormalities on pulmonary function testing and/or respiratory symptoms, and/or exercise-induced abnormalities.

Exclusion Criteria:

• Unable to understand protocol and to sign informed consent or not suitable candidate to comply with the requirements of this study, in the opinion of the investigator
• Cardiac and neurological sarcoidosis or any other organ involvement
• End stage lung disease at high-resolution computed tomography (HRCT)
• Clinical evidence of active infection
• Documented exposure to beryllium
• Patients with Forced Expiratory Volume at one second (FEV1) changes after salbutamol inhalation ≥20%
• Comorbidity: advanced liver cirrhosis or abnormal liver function, unstable cardiac disease, moderate to severe renal insufficiency, poorly controlled diabetes
• Pregnancy or lactation
• A tuberculin skin test (5 I.U.) more than 5 mm
• Psoriasis
• Homozygous glucose-6-phosphatase deficiency
• Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
• Visual field changes attributable to 4-aminoquinolines
• Concomitant therapies: any patient enrolled in the study must be off all prohibited medications at least 4 weeks before screening. Once patients completed the washout period, they may enter the screening period that may last up to 30 days
• Previous therapies: any patient enrolled must be off all medications for sarcoidosis at least 4 weeks before screening.