D86.0
Conditions
Interventions
Group 1: open, uncontrolled
50 microgramm Aviptadil four times daily per inhalation
Sponsors
mondoBIOTECH Laboratories Anstalt
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diagnosis: clinically active pulmonary sarcoidosis, with or without ocular sarcoidosis based on clinical history, and lung or intrathoracic lymph node biopsy, consistent with sarcoidosis with other causes of granuloma ruled out *Aged above 18 years *Written consent *Adequate contraception in female patients of childbearing age *Negative pregnancy test
Exclusion criteria
Exclusion criteria: *Lack of consent *Pregnancy and lactation *Presumed non-cooperativeness *Patients outside the stipulated age range *Malignant diseases in anamnesis *Legal incapacity *Parallel participation in another clinical trial *Clinical instability *Abnormal breathing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous production of TNF-alpha by BAL cells | — |
Secondary
| Measure | Time frame |
|---|---|
| a) changes in TGF beta1, TGF beta2, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10 and IFN-gamma; expression in alveolar macrophages; b) changes in the expression of the CD1a, CD1c, CD11a, CD11b, CD11c, CD18, CD20, CD40, CD54, CD58, CD68, CD80, CD83, CD86, CD123, HLA-DR cell surface marker of the alveolar macrophages of sarcoidosis patients; c) changes in the quality of life as recorded in appropriate questionnaire forms (SF36, EuroQol, St. George's Respiratory Questionnaire) d) clinical deterioration; e) Safety parameters * Vital signs * Body weight * Tolerance | — |
Countries
Germany
Contacts
Public ContactJoachim Müller-Quernheim
Universitätsklinikum Freiburg, Abteilung für Pneumologie
Outcome results
None listed