Antifungal medication improves treatment of sarcoidosis
| ISRCTN | ISRCTN34533986 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34533986 |
| Protocol serial number | N/A |
| Sponsor | University Hospital, Ljubljana (Slovenia) |
| Funder | Ljubljana Medical Centre (Slovenia) - Clinic of Respiratory Disease and Allergy |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Medical Center
Zaloska 7
Ljubljana
1000
Slovenia
| Phone | +386 (0)1 5222342 |
|---|---|
| marjeta.tercelj@kclj.si |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre 3 arm randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
None |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
1000
Slovenia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
