Status:

UNKNOWN

Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

Lead Sponsor:

St. Antonius Hospital

Conditions:

Sarcoidosis

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief 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...

Detailed Description

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 sar...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT01920919

Start Date

June 1 2013

Last Update

November 19 2014

Active Locations (1)

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St Antonius Hospital

Nieuwegein, Netherlands, 3430 EM