Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Antonius Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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