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

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ClinicalTrials.gov Identifier: NCT02200146
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
University of Milano Bicocca

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 high dose glucocorticoids at 3 and 9 months in patients with pulmonary sarcoidosis.

Condition or disease Intervention/treatment Phase
Pulmonary Sarcoidosis Drug: Prednisone Drug: Hydroxychloroquine + Prednisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). A Multicenter, Prospective, Controlled, Randomized Trial.
Study Start Date : March 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis Steroids

Arm Intervention/treatment
Active Comparator: Prednisone
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.
Drug: Prednisone
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.

Experimental: Hydroxychloroquine + Prednisone
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.
Drug: Hydroxychloroquine + Prednisone
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.




Primary Outcome Measures :
  1. The primary EFFICACY measure is the per-subject overall success rate at the 3 month visit. Overall response is defined as a combined radiographic and clinical responses. [ Time Frame: Baseline- After 3 months of treatment ]
    Subjects is considered clinically cured at the 3 month visit if they will have radiographic success (determined if Chest X-Ray is resolved or improved compared to the baseline; improvement was assessed if there were reduction in hilar adenopathies, less pulmonary involvement, changing in radiographic stage) PLUS a change in at least one of the followings: symptoms (determined by dyspnea or cough index score decrease compared to the baseline), and/or functional improvement (determined by an increase in % of predicted Forced Vital Capacity and/or increase in % of predicted Single-Breath Diffusion capacity of Lung for Carbon monoxide DLCO-SB compared to the baseline), and/or increase in resting Partial pressure of Oxygen in the artery blood (PaO2), and/or worst oxygen saturation increase during 6 Minute Walk Test (6MWT) and/or increase in distance walked at 6MWT, compared to the baseline

  2. The primary SAFETY endpoint is the percent change in lumbar spine (L1-L4) bone mineral density from baseline to month 9 as measured by Dual energy X-ray Absorptiometry (DXA) [ Time Frame: Baseline - After 9 months of treatment ]

Secondary Outcome Measures :
  1. Secondary EFFICACY endpoint was the change from baseline in radiographic success rate after 9 month of therapy (measured by High Resolution Chest Tomography HRCT) [ Time Frame: Baseline- After 9 months of therapy ]
    The radiographic success is determined if HRCT is resolved or improved compared to the baseline after 9 months

  2. Secondary SAFETY endpoint was the change from baseline in Body Mass Index [ Time Frame: Baseline - After 3, 6 and 9 months ]
  3. Secondary SAFETY endpoint was the change from baseline in HbA1c [ Time Frame: At 3, 6 and 9 months of therapy ]
  4. Secondary SAFETY endpoint was the change from baseline in clinical laboratory tests (including inflammatory markers) [ Time Frame: At 3, 6 and 9 months of therapy ]
  5. Secondary SAFETY endpoint was the change from baseline in bone turnover markers and mineral metabolism [ Time Frame: At months 3 and 9 from the start of therapy ]
  6. Secondary safety endpoint was the number of participants with Serious and Non-Serious Adverse Events [ Time Frame: Within the 9 months of therapy ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200146


Locations
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Italy
Università degli Studi di Milano - Bicocca
Milano, Italy, 20126
Sponsors and Collaborators
University of Milano Bicocca
Agenzia Italiana del Farmaco
Investigators
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Principal Investigator: Alberto Pesci Università Milano Bicocca
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT02200146    
Other Study ID Numbers: HySSAS-FARM639KLZ
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by University of Milano Bicocca:
sarcoidosis
treatment
lung
glucocorticoids
hydroxychloroquine
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Hydroxychloroquine
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents