Hydroxychloroquine as Steroid-Sparing Agent in pulmonary Sarcoidosis (HySSAS). A multicenter, prospectic, controlled, randomized trial. - HySSAS
- Conditions
- Pulmonary Sarcoidosis
- Registration Number
- EUCTR2008-001340-39-IT
- Lead Sponsor
- IVERSITA' DEGLI STUDI DI MILANO-BICOCCA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Sarcoidosis patients, with parenchymal pulmonary involvement at CXR with or without adenopathy, must have at least one of the
following lung disease activity signs: physiologic abnormalities on pulmonary function testing and/or respiratory symptoms, and/or
exercise-induced abnormalities. Physiologic abnormalities on pulmonary function testing will be defined as a value of less than 80%
predicted of the forced vital capacity (FVC), or DLCO-SB, or PaO2 <= 70 mmHg at rest. Respiratory symptoms will be defined as
significant cough and/or dyspnoea. Exercise-induced abnormalities: O2 saturation decrease of at least 5% during 6MWT;
distance walked <= 20% of predicted at 6MWT.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Disease-Related Exclusions: Unable to understand protocol and to sign informed consent; 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
or related condition requiring high dosage GCs treatment; End stage lung disease at HRCT ; Clinical evidence of
active infection; Documented exposure to beryllium; Patients with FEV1 changes after salbutamol inhalation >=20%
Medical and Laboratory Exclusions: History of advanced liver cirrhosis or abnormal liver function (SGOT and/or SGPT >= 3 x
upper limit of normal); History of unstable cardiac disease; Moderate to severe renal insufficiency; Poorly controlled diabetes
(defined by HbA1c >=10); Pregnancy or lactation (childbearing age female must be on effective contraceptive treatment an must
undergo pregnancy testing before start the treatment); 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 Therapy Exclusions: Any cytotoxic/immunosuppressive agent including but not limited to GCs at dosages higher than
those per protocol, azathioprine, cyclophosphamide, methotrexate, and cyclosporine; Any cytokine modulators (including but not
limited to etanercept, infliximab, pentoxifylline, thalidomide); Cimetidine, Digoxin, Phenothiazines, and Methadone (in the
hydroxychloroquine arm)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of the study is to determine the safety for a combination therapy with<br>hydroxychloroquine plus low dose GCs compared to that for high dose GCs at 3 and 9 months in patients with pulmonary<br>sarcoidosis.;Secondary Objective: The aim of the study is to determine the non-inferiority in the overall success rate for a combination therapy with<br>hydroxychloroquine plus low dose GCs compared to that for high dose GCs at 3 and 9 months in patients with pulmonary<br>sarcoidosis.;Primary end point(s): Bone Mineral Density. Lumbar spine (L1-L4) bone mineral density will be evaluated at the baseline and month 9 by DXA. The same<br>instrument will be used for serial DXA studies.
- Secondary Outcome Measures
Name Time Method