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

Last updated: July 24, 2014
Sponsor: University of Milano Bicocca
Overall Status: Completed

Phase

3

Condition

Sarcoidosis

Lung Disease

Treatment

N/A

Clinical Study ID

NCT02200146
HySSAS-FARM639KLZ
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Unable to understand protocol and to sign informed consent or not suitable candidateto 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 salbutamolinhalation ≥20%

  • Comorbidity: advanced liver cirrhosis or abnormal liver function, unstable cardiacdisease, 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 prohibitedmedications at least 4 weeks before screening. Once patients completed the washoutperiod, they may enter the screening period that may last up to 30 days

  • Previous therapies: any patient enrolled must be off all medications for sarcoidosisat least 4 weeks before screening.

Study Design

Total Participants: 94
Study Start date:
March 01, 2009
Estimated Completion Date:
September 30, 2013

Connect with a study center

  • Università degli Studi di Milano - Bicocca

    Milano, 20126
    Italy

    Site Not Available

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