Patients with newly diagnosed, pulmonary sarcoidosis
Conditions
Interventions
Trade Name: Dexamethasone 0,5mg
Product Name: Dexamethasone
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Current Sponsor code: Tiofarma
Other descriptive name: De
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this intervention study is to assess the effects of low-dose dexamethasone therapy on the quality of life of newly diagnosed sarcoidosis patients.;Secondary Objective: The secondary objectives are to assess the effects of low-dose dexamethasone therapy on (1) the total medical costs and work productivity of this population, (2) depression, fatigue and sleep quality, (3) the inflammatory profile and (4) disease progression and the need for additional pharmacotherapy;Primary end point(s): -Health-related quality of life measured by SF-36 (subscale physical functioning);Timepoint(s) of evaluation of this end point: one year after last patient included | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total medical resource utilisation - Work productivity - Cost-utility from a societal perspective - Depression - Fatigue - Quality of sleep - Cytokine profiles in plasma - Disease progression;Timepoint(s) of evaluation of this end point: 1 and 2 years after last patient included | — |
Countries
Netherlands
Outcome results
None listed