Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis

Phase 3

• Conditions: Sarcoidosis
• Interventions: Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT01920919
• Lead Sponsor: St. Antonius Hospital

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-08
• Study First Posted: 2013-08-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19
• Primary Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone 1 mg	Dexamethasone	Dexamethasone 1 mg per day, for 180 days
Placebo	Placebo	Placebo tablet, for 180 days

Primary Outcome Measures

Name	Time	Method
Change in health-related quality of life versus baseline	0, 3, 6, 12, 18, 24 months	The primary outcome measure is the change in health-related quality of life compared with baseline.

Trial Locations

Locations (1)

St Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands