D86.9
Conditions
Interventions
Group 1: All patients get HSP (Havelhöher Sarcoidosis Therapy Protocol), there is no control group.
Sponsors
Wala Heilmittel GmbH Pharmakologische und klinische Forschung
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Clinically and/or histologically confirmed diagnosis of sarcoidosis in the years 2005 to 2020. 2) Treatment with HSP 3) Documentation of therapy in the Turbomed database of the outpatient clinic or in Clinixx- documentation of the pulmonary department of the gemeinschaftskrankenhaus Havelhoehe 4) Age at least 18 years 5) Legal capacity 6) Voluntary and written informed consent before the start of the study.
Exclusion criteria
Exclusion criteria: 1) Clinically relevant concomitant conditions that unduly limit the assessment of efficacy and tolerability. These include: - confirmed autoimmune diseases - active tumor diseases - acute sarcoidosis (Löfgren's syndrome) - treatment with less than 1 cycle of HSP - incomplete data set (i.e., less than 2 radiographs during the course, less than 2 clinically defined measurement parameters documented below 80%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good disease control, improvement of changes in radiographic thorax, pulmonary function, clinical complaints (dyspnea, fatigue). | — |
Secondary
| Measure | Time frame |
|---|---|
| In patients with treatment failure of oral glucocorticoid therapy alone, HSP may eliminate the need for escalation to additional immunosuppressive therapy. HSP can improve the fatigue that often accompanies it. HSP has a very good safety profile. There is a very low incidence of serious adverse events, adverse drug reactions, and serious adverse drug reactions. Therapy with HSP has a high compliance. | — |
Countries
Germany
Contacts
Public ContactChristian Grah
Forschungsinstitut Havelhöhe gGmbH am GKH Havelhöhe
Outcome results
None listed