D83.9 J84.8
Conditions
Interventions
Group 1: The natural course of the disease will be obeserved in patients not receiving any immunosuppressive therapy.
Group 2: The natural course of the disease will be obeserved in patients receiving
Sponsors
Universitätsklinikum Freiburg
Centrum für Chronische Immundefizienz (CCI)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of CVID according to ESID/PAGID criteria; Interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs; Signed written informed consent.
Exclusion criteria
Exclusion criteria: Patient without legal capacity who is unable to understand the nature, significance and consequences of the study; No written consent available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function parameter Diffusing Capacity of the Lung for Carbon Monoxide Single Breath (DLCOc SB). Will be measured routinely at every visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other lung function parameters (routinely at every visit). Overall Survival. Quality of life (SF36,CRDQ und SGRQ will be compared over the whole study). Number, type and severity of infections (documented in the CRF at every visit). Number, type and severity of other side effects of immunosuppressive therapy (only if judged by the treating physician as possibly related to the applied therapy, will be documented in the CRF). The following parameters will be documented over the whole study whenever obtained as clinically indicated: Laboratory blood tests parameters; Cyto-/histological evaluation of the lung; Lung CT scans; Cardiac parameters; | — |
Countries
France, Germany, United Kingdom
Contacts
Public ContactSigune Goldacker
Universitätsklinikum Freiburg Centrum für Chronische Immundefizienz (CCI)
Outcome results
None listed