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History of Changes for Study: NCT01920919
Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis (DEXSAR)
Latest version (submitted November 18, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 8, 2013 None (earliest Version on record)
2 November 18, 2014 Recruitment Status, Study Status and Eligibility
Comparison Format:

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Study NCT01920919
Submitted Date:  August 8, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2013-000242-18
Brief Title: Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis (DEXSAR)
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2013
Overall Status: Recruiting
Study Start: June 2013
Primary Completion: August 2015 [Anticipated]
Study Completion:
First Submitted: August 7, 2013
First Submitted that
Met QC Criteria:
August 8, 2013
First Posted: August 12, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 8, 2013
Last Update Posted: August 12, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: St. Antonius Hospital
Responsible Party: Principal Investigator
Investigator: R Vis
Official Title: Hospital Pharmacist
Affiliation: St. Antonius Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
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.

Open or close this module Conditions
Conditions: Sarcoidosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 76 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dexamethasone 1 mg
Dexamethasone 1 mg per day, for 180 days
Drug: Dexamethasone
Placebo Comparator: Placebo
Placebo tablet, for 180 days
Drug: Placebo
Open or close this module 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
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 < 60 points

Exclusion Criteria:

  • Lofgren's syndrome
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Roeland Vis
Telephone: 0031 30 609 2612
Email: r.vis@antoniusziekenhuis.nl
Locations: Netherlands
St Antonius Hospital
[Recruiting]
Nieuwegein, Netherlands, 3430 EM
Contact:Principal Investigator: Roeland Vis
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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