Antifungal medication improves treatment of sarcoidosis

ISRCTN	ISRCTN34533986
DOI	https://doi.org/10.1186/ISRCTN34533986
Secondary identifying numbers	N/A

Submission date: 08/07/2010
Registration date: 29/07/2010
Last edited: 08/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marjeta Tercelj
Scientific

University Medical Center
Zaloska 7
Ljubljana
1000
Slovenia

Phone	+386 (0)1 5222342
Email	marjeta.tercelj@kclj.si

Study information

Study design	Single centre 3 arm randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patients received oral advice, therefore patient information sheet is not available. Contact [envhealth@biofact.se] for further information.
Scientific title	Antifungal medication improves treatment of sarcoidosis: A three arm, randomised controlled trial
Study acronym	AFS
Study objectives	Treatment with antifungal agents would be more efficient than treatment with corticosteroids only
Ethics approval(s)	Approved by the ethical committee at the University Medical Centre, Ljubljana, Slovenia (ref: 85/05/04)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/08/2003
Completion date	31/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Key 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
Key exclusion criteria	Severe sarcoidosis requiring immediate treatment
Date of first enrolment	15/08/2003
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

Slovenia

Study participating centre

University Medical Center

Ljubljana
1000
Slovenia

Sponsor information

University Hospital, Ljubljana (Slovenia)
Hospital/treatment centre

Zaloska 7
Ljubljana
1000
Slovenia

Phone	+386 (0)1 5222342
Email	simon.vrhunec@kclj.si
"ROR"	https://ror.org/01nr6fy72

Funders

Funder type

Hospital/treatment centre

Ljubljana Medical Centre (Slovenia) - Clinic of Respiratory Disease and Allergy

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2011		Yes	No