Study of interstitial lung disease in primary antibody deficiency

• Conditions: D83.9; J84.8; Common variable immunodeficiency, unspecified; Other specified interstitial pulmonary diseases

• Registration Number: DRKS00000799
• Lead Sponsor: niversitätsklinikum FreiburgCentrum für Chronische Immundefizienz (CCI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-28
• Study Completion: 2017-12-31
• Results First Posted: 2020-10-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 150

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

Patient without legal capacity who is unable to understand the nature, significance and consequences of the study; No written consent available.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ung function parameter Diffusing Capacity of the Lung for Carbon Monoxide Single Breath (DLCOc SB). Will be measured routinely at every visit.

Secondary Outcome Measures

Name	Time	Method
Other lung function parameters (routinely at every visit).<br>Overall Survival.<br>Quality of life (SF36,CRDQ und SGRQ will be compared over the whole study).<br>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).<br>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; <br>