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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01920919
Recruitment Status : Unknown
Verified November 2014 by R Vis, St. Antonius Hospital.
Recruitment status was:  Recruiting
First Posted : August 12, 2013
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
R Vis, St. Antonius Hospital

Tracking Information
First Submitted Date  ICMJE August 7, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date November 19, 2014
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose Dexamethasone in Newly Diagnosed Pulmonary Sarcoidosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sarcoidosis
Intervention  ICMJE
  • Drug: Dexamethasone
  • Drug: Placebo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
76
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920919
Other Study ID Numbers  ICMJE 2013-000242-18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party R Vis, St. Antonius Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE St. Antonius Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Antonius Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP