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Completed

NCT Number: NCT02200146

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

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.

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Key information

Conditions

Pulmonary Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Respiratory Tract Diseases Sarcoidosis Sarcoidosis, Pulmonary

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Università degli Studi di Milano - Bicocca

Milan, Milano, 20126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisone

Drug

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.

Hydroxychloroquine + Prednisone

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • Agenzia Italiana del Farmaco

Registry information

Official study title

Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). A Multicenter, Prospective, Controlled, Randomized Trial.

Acronym: HySSAS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2014
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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