ow dose dexamethasone in newly diagnosed sarcoidosis

• Conditions: Patients with newly diagnosed, pulmonary sarcoidosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-000242-18-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-11
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of sarcoidosis (confirmed by histology or cytology) in the past 3 months
•Age between 18 and 55 years
•No affected organ requiring high dose immunosuppressive therapy
•SF-36 subscale physical functioning (SF-36 PF) score < 60 points

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 76
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Löfgren's syndrome
•Allergy to corticosteroids
•Diagnosis of glaucoma
•Diagnosis of osteoporosis or history of fractures
•History of gastric ulcera in the past 12 months
•Current use of NSAIDs without co-prescription of a PPI
•Current use of potent inducer of cytochrome P450 liver enzymes (carbamazepin, fenytoin, rifampicin)
•Obesity (BMI > 30)
•Pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified