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

• ClinicalTrials.gov Identifier: NCT01920919
• Recruitment Status: Unknown
• First Posted: August 12, 2013
• Last Update Posted: November 19, 2014
• Sponsor: St. Antonius Hospital
• Information provided by (Responsible Party): R Vis, St. Antonius Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sarcoidosis	Drug: Dexamethasone; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: June 2013
• Estimated Primary Completion Date: August 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Roeland Vis; 0031 30 609 2612; r.vis@antoniusziekenhuis.nl

Locations

Netherlands

St Antonius Hospital; Recruiting

Nieuwegein, Netherlands, 3430 EM

Principal Investigator: Roeland Vis

Sponsors and Collaborators

St. Antonius Hospital

More Information

• Responsible Party: R Vis, Hospital Pharmacist, St. Antonius Hospital
• ClinicalTrials.gov Identifier: NCT01920919
• Other Study ID Numbers: 2013-000242-18
• First Posted: August 12, 2013
• Last Update Posted: November 19, 2014
• Last Verified: November 2014

Additional relevant MeSH terms:

Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Dexamethasone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents