Condition category
Haematological Disorders
Date applied
08/07/2010
Date assigned
29/07/2010
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes