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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by St. Antonius Hospital
Sponsor:
Information provided by (Responsible Party):
R Vis, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01920919
First received: August 7, 2013
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Sarcoidosis
Drug: Dexamethasone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Change in health-related quality of life versus baseline [ Time Frame: 0, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    The primary outcome measure is the change in health-related quality of life compared with baseline.


Estimated Enrollment: 76
Study Start Date: June 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: R Vis, Hospital Pharmacist, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01920919     History of Changes
Other Study ID Numbers: 2013-000242-18
Study First Received: August 7, 2013
Last Updated: August 8, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014