Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis (DEXSAR)

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.

Study Overview

• Status: Unknown
• Conditions: Sarcoidosis
• Intervention / Treatment: Drug: Placebo; Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Nieuwegein, Netherlands, 3430 EM
    • Recruiting
    • St Antonius Hospital
    • Principal Investigator: Roeland Vis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone 1 mg; Dexamethasone 1 mg per day, for 180 days	Drug: Dexamethasone
Placebo Comparator: Placebo; Placebo tablet, for 180 days	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 12, 2013

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphoproliferative Disorders; Lymphatic Diseases; Sarcoidosis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 2013-000242-18