Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

Sarcoidosis Clinical Trial

— DEXSAR  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01920919
• Other study ID #: 2013-000242-18
• Status: Recruiting
• Phase: Phase 3
• First received: August 7, 2013
• Last updated: November 18, 2014
• Start date: June 2013

Study information

• Verified date: November 2014
• Source: St. Antonius Hospital
• Contact: Roeland Vis
• Phone: 0031 30 609 2612
• Email: r.vis[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• Dexamethasone

• Placebo

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health-related quality of life versus baseline	The primary outcome measure is the change in health-related quality of life compared with baseline.	0, 3, 6, 12, 18, 24 months	No