EUCTR2008-001340-39-IT进行中（未招募）不适用
Hydroxychloroquine as Steroid-Sparing Agent in pulmonary Sarcoidosis (HySSAS). A multicenter, prospectic, controlled, randomized trial. - HySSAS
IVERSITA' DEGLI STUDI DI MILANO-BICOCCA0 个研究点开始时间: 2008年6月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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