Contact information
Type
Scientific
Primary contact
Dr Marjeta Tercelj
ORCID ID
Contact details
University Medical Center
Zaloska 7
Ljubljana
1000
Slovenia
+386 (0)1 5222342
marjeta.tercelj@kclj.si
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Antifungal medication improves treatment of sarcoidosis: A three arm, randomised controlled trial
Acronym
AFS
Study hypothesis
Treatment with antifungal agents would be more efficient than treatment with corticosteroids only
Ethics approval
Approved by the ethical committee at the University Medical Centre, Ljubljana, Slovenia (ref: 85/05/04)
Study design
Single centre 3 arm randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patients received oral advice, therefore patient information sheet is not available. Contact [envhealth@biofact.se] for further information.
Condition
Pulmonary sarcoidosis
Intervention
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.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measures
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
Secondary outcome measures
None
Overall trial start date
15/08/2003
Overall trial end date
31/07/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Severe sarcoidosis requiring immediate treatment
Recruitment start date
15/08/2003
Recruitment end date
31/07/2010
Locations
Countries of recruitment
Slovenia
Trial participating centre
University Medical Center
Ljubljana
1000
Slovenia
Sponsor information
Organisation
University Hospital, Ljubljana (Slovenia)
Sponsor details
Zaloska 7
Ljubljana
1000
Slovenia
+386 (0)1 5222342
simon.vrhunec@kclj.si
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Ljubljana Medical Centre (Slovenia) - Clinic of Respiratory Disease and Allergy
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in www.ncbi.nlm.nih.gov/pubmed/21436319
Publication citations
-
Results
Tercelj M, Salobir B, Zupancic M, Rylander R, Antifungal medication is efficient in the treatment of sarcoidosis., Ther Adv Respir Dis, 2011, 5, 3, 157-162, doi: 10.1177/1753465811401648.