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Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01920919
Acronym
DEXSAR
Enrollment
76
Registered
2013-08-12
Start date
2013-06-30
Completion date
Unknown
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

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 symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

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 sarcoidosis, multiple organs are affected by inflammation; the cause of the disease is unknown and no curative medication exists. Sarcoidosis invalidates the lives of most patient for many years. Although curative (pharmaco) therapy is not on hand, immunosuppressive drugs may control the symptoms of the disease. These symptoms are caused by the inflammation in multiple organs, foremost the lungs and the lymphoid system. However, 90% of the sarcoidosis patients receives no immunosuppressive medication at all during the first months after diagnosis, even though the immune system is then highly activated and patients suffer from severe complaints like malaise, fatigue and pain. This wait-and-see policy is common international practice, but scientific grounds and official guidelines are lacking. This project 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.

Interventions

DRUGDexamethasone
DRUGPlacebo

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in health-related quality of life versus baseline0, 3, 6, 12, 18, 24 monthsThe primary outcome measure is the change in health-related quality of life compared with baseline.

Countries

Netherlands

Contacts

Primary ContactRoeland Vis
r.vis@antoniusziekenhuis.nl0031 30 609 2612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026