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临床试验/NCT01920919
NCT01920919Unknown3 期

Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
76
试验地点
1
主要终点
Change in health-related quality of life versus baseline

研究概览

简要总结

This trial examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

详细描述

The orphan disease sarcoidosis causes a major reduction in quality of life and loss of work productivity, especially in young adults. Most patients are diagnosed between the age of 20-40 years. In sarcoidosis, multiple organs are affected by inflammation; the cause of the disease is unknown and no curative medication exists. Sarcoidosis invalidates the lives of most patient for many years.

Although curative (pharmaco) therapy is not on hand, immunosuppressive drugs may control the symptoms of the disease. These symptoms are caused by the inflammation in multiple organs, foremost the lungs and the lymphoid system. However, 90% of the sarcoidosis patients receives no immunosuppressive medication at all during the first months after diagnosis, even though the immune system is then highly activated and patients suffer from severe complaints like malaise, fatigue and pain. This wait-and-see policy is common international practice, but scientific grounds and official guidelines are lacking.

This project examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of sarcoidosis, confirmed by histology or cytology
  • Age 18-60 years
  • No affected organ requiring high dose immunosuppressive therapy
  • Short Form - 36 subscale physical functioning score < 70 points

排除标准

  • Allergy to corticosteroids
  • Diagnosis of glaucoma, osteoporosis, history of fractures
  • History of gastric ulcera in the past 12 months
  • Current use of Non Steroidal Anti Inflammatory Drug without co-prescription of Proton Pump Inhibitor
  • Current use of carbamazepin, fenytoin, rifampicin
  • Obesity (BMI > 30)
  • Pregnancy of lactation

研究组 & 干预措施

Dexamethasone 1 mg

Experimental

Dexamethasone 1 mg per day, for 180 days

干预措施: Dexamethasone (Drug)

Placebo

Placebo Comparator

Placebo tablet, for 180 days

干预措施: Placebo (Drug)

结局指标

主要结局

Change in health-related quality of life versus baseline

时间窗: 0, 3, 6, 12, 18, 24 months

The primary outcome measure is the change in health-related quality of life compared with baseline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

R Vis

Hospital Pharmacist

St. Antonius Hospital

研究点 (1)

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