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

Tracking Information

• First Submitted Date: August 7, 2013
• First Posted Date: August 12, 2013
• Last Update Posted Date: November 19, 2014
• Study Start Date: June 2013
• Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 8, 2013)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis
• Official Title: Not Provided
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Sarcoidosis

Intervention

• Drug: Dexamethasone
• Drug: Placebo

Study Arms

• Experimental: Dexamethasone 1 mg
  Dexamethasone 1 mg per day, for 180 days
  Intervention: Drug: Dexamethasone
• Placebo Comparator: Placebo
  Placebo tablet, for 180 days
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 8, 2013): 76
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01920919
• Other Study ID Numbers: 2013-000242-18
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: R Vis, St. Antonius Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: St. Antonius Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: St. Antonius Hospital
• Verification Date: November 2014