Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis (DEXSAR)
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Change in health-related quality of life versus baseline [ Time Frame: 0, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]The primary outcome measure is the change in health-related quality of life compared with baseline.
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Dexamethasone 1 mg
Dexamethasone 1 mg per day, for 180 days
Placebo Comparator: Placebo
Placebo tablet, for 180 days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920919
|St Antonius Hospital|
|Nieuwegein, Netherlands, 3430 EM|