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

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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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis
U.S. FDA Resources

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



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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920919


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

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

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action