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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milano Bicocca
• Collaborator: Agenzia Italiana del Farmaco
• Treatments: Hydroxychloroquine; Prednisone

Criteria

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.