ow dose dexamethasone in newly diagnosed sarcoidosis

Phase 4

Completed

• Conditions: sarcoidosis; Besnier-Boeck disease; 10006436

• Registration Number: NL-OMON40492
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

-Diagnosis of sarcoidosis conforming with ATS criteria (confirmed by histology or cytology) in the past 6 months
-Age between 18 and 60 years
-No affected organ requiring high dose immunosuppressive therapy
-SF-36 subscale physical functioning (SF-36 PF) score * 70 points

Exclusion Criteria

-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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Health-related quality of life measured by SF-36 (subscale physical<br /><br>functioning)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Total medical resource utilisation<br /><br>- Work productivity<br /><br>- Cost-utility from a societal perspective<br /><br>- Depression<br /><br>- Fatigue<br /><br>- Quality of sleep<br /><br>- Cytokine profiles in plasma<br /><br>- Disease progression</p><br>