J44.9 J45.9
Conditions
Interventions
Group 1: Patients with obstructive lung diseases who are newly treated with targeted therapies are observed longitudinally. Data from routine clinical practice, such as physical examinations, lung fun
Sponsors
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female and male patients aged = 18 years (at the time of written consent) with no upper age limit. 2. Written informed consent is available. 3. Confirmed diagnosis of COPD grade B or E, or severe bronchial asthma. 4. First prescription of a biologic therapy or use of ongoing inhalation therapy (initial therapy not mandatory). 5. Ability to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding mothers 2. Anemia with a hemoglobin value < 10 g/dl 3. Exclusion criteria are generally also defined by the contraindications for biologic therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapy response measured by an improvement in FEV1 or a reduction in exacerbations after 12 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in inflammation-related biomarkers (e.g. eosinophils) 2. Improvement in quality of life assessed by specific questionnaires 3. Frequency of hospitalizations and emergency treatments Exploratory endpoints: 1. Changes in the transcriptome, proteome, methylation patterns, microbiome, and metabolome, and their correlation with response to therapy 2. Imaging data from routine clinical practice for the detection of structural airway changes (no radiographic examinations are performed as part of the study; imaging is limited to standard clinical care) | — |
Countries
Germany
Contacts
Public ContactKatharina Koethke
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Outcome results
None listed