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

University of Milano Bicocca

Status and phase: Completed; Phase 3

Conditions: Pulmonary Sarcoidosis

Treatments: Drug: Hydroxychloroquine + Prednisone; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT02200146

HySSAS-FARM639KLZ

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Prednisone

Active Comparator group

Description:

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.

Treatment:

Drug: Prednisone

Hydroxychloroquine + Prednisone

Experimental group

Description:

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.

Treatment:

Drug: Hydroxychloroquine + Prednisone