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ISRCTN
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ISRCTN34533986
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ClinicalTrials.gov identifier
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Public title
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Antifungal medication improves treatment of sarcoidosis
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Scientific title
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Antifungal medication improves treatment of sarcoidosis: A three arm, randomised controlled trial
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Acronym
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AFS
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Serial number at source
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N/A
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Study hypothesis
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Treatment with antifungal agents would be more efficient than treatment with corticosteroids only
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Lay summary
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Ethics approval
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Approved by the ethical committee at the University Medical Centre, Ljubljana, Slovenia (ref: 85/05/04)
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Study design
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Single centre 3 arm randomised active controlled parallel group trial
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Countries of recruitment
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Slovenia
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Disease/condition/study domain
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Pulmonary sarcoidosis
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Participants - inclusion criteria
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1. Subjects with sarcoidosis diagnosed using established criteria at the Department of Pulmonary and Allergic diseases at the Medical Center, University hospital of Ljubljana, Slovenia.
2. Informed consent
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Participants - exclusion criteria
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Severe sarcoidosis requiring immediate treatment
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Anticipated start date
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15/08/2003
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Anticipated end date
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31/07/2010
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Status of trial
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Completed |
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Patient information material
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Patients received oral advice, therefore patient information sheet is not available. Contact [envhealth@biofact.se] for further information.
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Target number of participants
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20
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Interventions
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1. Corticosteroid (12 - 16 mg methylprednisolone every second day)
2. Itraconazol (200 mg daily)
3. Corticosteroid and Itraconazol in combination
Patients were controlled at 2-3 months. The total duration of treatment was 6 months and the effect of the treatment was evaluated at the end of this time.
Results:
The X-ray score decreased significantly more among subject who received antifungal medication, with or without corticosteroids. The results thus suggest that the antifungal treatment is efficient against the causative agent in sarcoidosis.
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Primary outcome measure(s)
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1. X-ray was taken before and after treatment. A grading scheme for the presence of granulomas was used as described previously. The x-rays were read by two experienced radiologists, unaware of the status of the patient, grading granulomas according to a numerical score (0-4), judging size and extension of the infiltrates (0 = normal, 1= ca 25% of lung field involved, 2 = up to 50%, 3 = up to 75%, and 4 = virtually the whole lung field involved). Repeat evaluations on two successive occasions showed only minor deviations in the classification.
2. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) was measured using standard techniques
3. Inflammatory indicators of sarcoidosis were determined
3.1. The soluble IL-2 receptor (sIL-2R) in serum was quantified using an ELISA commercial kit (Milenia Biotech, Badnauheim, Gemany) and expressed as U/mL
3.2. Angiotensin converting enzyme in serum (sACE) was determined using a colorimetric method and expressed as ìKat/L
3.3. Chitotriosidase (CTO) activity in serum was determined
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Secondary outcome measure(s)
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None
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Sources of funding
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Ljubljana Medical Centre (Slovenia) - Clinic of Respiratory Disease and Allergy
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Trial website
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Publications
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Contact name
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Dr
Marjeta
Tercelj
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Address
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University Medical Center
Zaloska 7
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City/town
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Ljubljana
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Zip/Postcode
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1000
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Country
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Slovenia
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Tel
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+386 (0)1 5222342
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Email
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marjeta.tercelj@kclj.si
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Sponsor
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University Hospital, Ljubljana (Slovenia)
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Address
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Zaloska 7
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City/town
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Ljubljana
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Zip/Postcode
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1000
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Country
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Slovenia
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Tel
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+386 (0)1 5222342
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Email
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simon.vrhunec@kclj.si
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Date applied
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08/07/2010
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Last edited
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29/07/2010
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Date ISRCTN assigned
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29/07/2010
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