Status:
COMPLETED
Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS).
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Conditions:
Pulmonary Sarcoidosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT02200146
Start Date
March 1 2009
End Date
September 1 2013
Last Update
July 25 2014
Active Locations (1)
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1
Università degli Studi di Milano - Bicocca
Milan, Milano, Italy, 20126