Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Sarcoidosis

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone 1 mg<br>Dexamethasone 1 mg per day, for 180 days | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: Placebo<br>Placebo tablet, for 180 days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life versus baseline | The primary outcome measure is the change in health-related quality of life compared with baseline. | 0, 3, 6, 12, 18, 24 months |