Systematic retrospective evaluation of patients with sarcoidosis treated with the Havelhöher Sarcoidosis Therapy Protocol (HSP)
- Conditions
- D86.9Sarcoidosis, unspecified
- Registration Number
- DRKS00029126
- Lead Sponsor
- Wala Heilmittel GmbH Pharmakologische und klinische Forschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
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.
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%)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Good disease control, improvement of changes in radiographic thorax, pulmonary function, clinical complaints (dyspnea, fatigue).
- Secondary Outcome Measures
Name Time Method In patients with treatment failure of oral glucocorticoid therapy alone, HSP may eliminate the need for escalation to additional immunosuppressive therapy.<br>HSP can improve the fatigue that often accompanies it.<br>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.<br>Therapy with HSP has a high compliance.