Center for Clinical Studies
As the clinical study center, we serve as a key interface for translating experimental research into patient care. In close collaboration with the Medical Service Center MVZ Borstel and the BioMaterialBank Nord, we translate findings from basic science into clinical research and support research groups from both program areas in planning, applying for, and conducting clinical studies.
Our studies focus on both communicable and non-communicable respiratory diseases, particularly asthma, allergies, COPD, pneumonia, tuberculosis, non-tuberculous mycobacteria, and other pulmonary conditions. Our core expertise lies in the design and implementation of observational studies, clinical intervention trials (Phase III), post-marketing studies (Phase IV), and medical device trials - in close collaboration with basic scientists in Borstel, pulmonology and infectious disease societies, and partners from the pharmaceutical industry. To this end, we operate as a flying study team both on-site and at major hospitals in the region: Leibniz Lung Clinic, University Medical Center Schleswig-Holstein (UKSH) Campus Kiel, UKSH Campus Lübeck, and University Medical Center Hamburg-Eppendorf.
BMBN
- Project Lead: PD Dr. med. Karoline Gaede, Research Center Borstel, Leibniz Lung Center
- Under the umbrella of the BioMaterialBank Nord and in cooperation with the Medical Service Center MVZ Borstel, we collect biomaterial samples from patients with asthma, chronic obstructive pulmonary disease (COPD), and allergies, with a focus on blood, sputum, urine, and stool. These samples are made available by BioMaterialBank Nord to researchers - including working groups in Borstel and Kiel, as well as across Germany and Europe. In this way, the BioMaterialBank Nord, MVZ Borstel, and the clinical study center form a bridge between patient care and basic science - locally, nationally, and internationally.
- Individuals interested in participating in this project are very welcome to contact us for further information!
COSYCONET II & PerMed COPD
- Project Lead: Prof. Dr. med. Claus Vogelmeier, University Hospital Marburg
- Local Project Leads: PD Dr. med. Barbara Kalsdorf (PerMed COPD); Prof. Dr. med. Christoph Lange (COSYCONET II), Research Center Borstel, Leibniz Lung Center
- COSYCONET II is a nationwide cohort study in Germany that thoroughly investigates the disease course of chronic obstructive pulmonary disease (COPD) in a large patient population, aiming to provide insights into disease mechanisms and therapeutic strategies.
- PerMed COPD is conducted under the German Medical Device Regulation and builds on the COSYCONET cohort results. It evaluates a software tool designed to support optimized, personalized treatment strategies for COPD patients.
- Individuals with COPD who are interested in participating in the PerMed COPD study are welcome to contact us for more information!
Oz-leap
- Oz-leap is a post-marketing study investigating the effects of Pitolisant (Ozawade®). The study is aimed at individuals experiencing pronounced daytime sleepiness.
- Individuals interested in participating are welcome to contact us for more information!
DetecTB
- Project Lead: PD Dr. med. Thomas Brehm, Research Center Borstel, Leibniz Lung Center
- The aim of the DetecTB study is to systematically evaluate several innovative diagnostic methods for tuberculosis in parallel. In individuals with suspected TB, six novel tests are applied and directly compared. These include, for example, the detection of the TB-specific lipopolysaccharide lipoarabinomannan (LAM) in urine and sputum, molecular analysis of mycobacterial DNA in stool using a new detection method, and the identification of circulating cell-free TB DNA (cfDNA) in blood. The DetecTB study exemplifies the successful integration of clinical care and research and highlights the close collaboration between the Research Center Borstel and the University Medical Center Hamburg-Eppendorf (UKE) in the field of tuberculosis research.
OXIGENE
- Scientific Project Lead: Dr. rer. nat. Tobias Dallenga, Research Center Borstel, Leibniz Lung Center
- Medical Project Lead: Prof. Dr. med. Jan Heyckendorf, University Medical Center Schleswig-Holstein
- The OXIGENE study investigates the effects of oxidized antigens on T-cell responses and the epigenetic reprogramming of neutrophils in lung diseases. It aims to characterize immune responses of specific defense cells across various pulmonary conditions, including asthma, COPD, pneumonia, tuberculosis, and viral lung infections (COVID-19, influenza).
- Individuals with asthma or COPD who are interested in participating are welcome to contact us for more information!
NTMecoCF
- Scientific Project Lead: Dr. ir. Margo Diricks, Research Center Borstel, Leibniz Lung Center
- Medical Project Lead: Prof. Dr. med. Alexander Mischnik, Research Center Borstel, Leibniz Lung Center
- The NTMecoCF study analyzes environmental samples (water, dust, and, if applicable, soil) from the surroundings of individuals with cystic fibrosis to detect non-tuberculous mycobacteria (NTM). The aim is to determine whether these infections may originate from environmental sources and whether behavioral risk factors play a role.
PK<>MB
- Scientific Project Lead: Prof. Dr. rer. nat. Matthias Merker, Research Center Borstel, Leibniz Lung Center
- This project investigates the relationship between the gut microbiome and drug concentrations in the blood of patients with tuberculosis. The central focus is not only on how medications affect the microbiome, but especially on how the microbiome influences the pharmacokinetics of the drugs—particularly that of rifampicin. The study is planned in cooperation with the BioMaterialBank Nord at the University Medical Center Schleswig-Holstein, Campus Kiel.
DTox-TB
- Project Lead: Dr. med. Niklas Köhler, Research Center Borstel, Leibniz Lung Center
- DTox-TB investigates the relationship between the leukocyte transcriptome and the occurrence of hepatotoxic side effects caused by the four standard antibiotics used in tuberculosis treatment: rifampicin, isoniazid, ethambutol, and pyrazinamide. The goal is to develop a predictive signature that can indicate the risk of drug-induced toxicity even before the start of therapy. Patients will be recruited at multiple centers, including sites in Moldova, Romania, Latvia, and Lithuania.
MBLA_IRIS
- Project Lead: PD Dr. med. Thomas Brehm, Research Center Borstel, Leibniz Lung Center
- This prospective, multicenter study investigates patients with tuberculous lymphadenitis who, after more than three months of therapy, develop paradoxical lymph node swelling and/or suspected abscess formation and for whom fine-needle aspiration under ultrasound guidance is clinically indicated. In addition to standard diagnostic procedures, a novel MBLA test will be performed at the Research Center Borstel, provided sufficient material is available. Patients will be clinically monitored to assess treatment decisions and outcomes. MBLA results will be compared with those from Xpert MTB/RIF and culture. The study is conducted across several European centers within the framework of TBnet e.V.
TBnet Registry
- Project Lead: Anca Vasiliu MD PhD, Research Center Borstel, Leibniz Lung Center
- For clinical research on the epidemiology, prevention, diagnosis, and treatment of tuberculosis, the systematic collection and evaluation of patient data is essential—particularly to include risk groups and address rare forms of the disease (e.g., MDR-TB, extrapulmonary TB). To this end, the TBnet e.V. research network, founded in 2006 in Schleswig-Holstein, is establishing a tuberculosis registry. This registry will store long-term datasets from TB patients in Schleswig-Holstein and other participating TBnet partner institutions across Europe. Collected data include risk factors, preventive measures, diagnostic results (microbiology, resistance patterns, imaging), treatment details and side effects, therapy outcomes (even years later), and long-term complications. This comprehensive data foundation will be used to explore strategies for improved prevention and treatment of tuberculosis.
ASTRA – Albanian Study on Tuberculosis Respiratory SequelAe
- Project Leads: PD Dr. med. Thomas Brehm, Research Center Borstel, Leibniz Lung Center / Prof. Dr. Silvana Bala, Shefqet Ndroqi Regional Hospital, Tirana
- This prospective observational cohort study investigates the prevalence and short-term progression of post-tuberculosis lung disease (PTLD) in TB survivors in Albania. The study assesses the degree of lung function impairment, reduced physical capacity, and depressive symptoms in patients 6 to 30 months after completing TB therapy. Participants undergo various non-invasive assessments, including spirometry, a six-minute walk test, and validated questionnaires to evaluate symptoms, quality of life, and mental health. The study provides valuable insights into the burden of PTLD in Albania—where such data have so far been lacking—and supports the development of future treatment strategies for PTLD management.
TBpredict
- Project Leads: PD Dr. med. Thomas Brehm, Assoc. Prof. Dr. Dumitru Chesov, MD PhD, Research Center Borstel, Leibniz Lung Center / Nicolae Testemițanu State University of Medicine and Pharmacy, Republic of Moldova
- This prospective cohort study, conducted at the Chiril Draganiuc Institute of Phthisiopneumology in Chișinău (Moldova), investigates whether early microbiological and immunological treatment responses can predict long-term lung function in patients with MDR/RR tuberculosis. During the intensive treatment phase, molecular diagnostics (MBLA, LAM) and transcriptome analyses are regularly performed and correlated with functional parameters such as spirometry, six-minute walk test, and blood gas analysis. The aim is to identify early biomarkers that can indicate the risk of developing post-tuberculosis lung disease (PTLD).
NTMdiary
- Project Lead: PD Dr. med. Thomas Brehm
- The treatment monitoring of non-tuberculous mycobacterial (NTM) lung infections currently relies primarily on microbiological and radiological examinations. However, these methods can be unreliable, burdensome, or difficult to perform—for example, due to limited sputum production or cumulative radiation exposure from repeated CT scans. There is a clear need for simple, non-invasive tools to monitor disease progression. This study aims to systematically evaluate the use of patient diaries as an instrument to track health status and quality of life in individuals with NTM lung disease, offering a new approach to the early detection of disease progression or treatment failure.
mEX-TB
- Project Leads: Prof. Dr. med. Jan Rybniker, PD Dr. med. Isabella Suárez
- Local Project Lead: Prof. Dr. med. Dr. h.c. Christoph Lange
- This prospective, multicenter study aims to improve the care of patients with extrapulmonary tuberculosis and to identify biomarkers that signal the development of extrapulmonary TB. These markers may enable future biomarker-based diagnostics and targeted treatments. Clinical data and biosamples from patients with extrapulmonary TB have been collected at six sites, including the University Medical Center Schleswig-Holstein, Campus Kiel. Since early 2026, patient recruitment and follow-up have been completed, and centralized analysis of samples and data is now underway.
- 3 study nurses with clinical trial associate training (CTA) and IATA certification
- 2 study physicians trained in CTR and MDR
- Database design and management
- Body plethysmography
- Pulmonary function testing
- Sonography
- Audiometry
- ECG and ankle-brachial index measurement
- FeNO and blood gas analysis
- Bioimpedance analysis
- Sputum induction
2026
Behrens, E, Köhler, N, Münchow, M, Zielinski, N, Pfaffendorf, C, Grobbel, H-P, Schaub, D, Reimann, M, Sánchez Carballo, PM, Kalsdorf, B, Hillemann, D, Kuhns, M, Hofmann-Thiel, S, Hoffmann, H, Decosterd, LA, Choong, E, Aarnoutse, R, Lange, C & Wicha, SG 2026, 'Towards model-informed precision dosing of clofazimine, moxifloxacin, and terizidone/cycloserine in the treatment of drug-resistant tuberculosis: An external model evaluation study', Tuberculosis, Jg. 157, S. 102744. https://doi.org/10.1016/j.tube.2026.102744
Klingmüller, A, Zuber, S, Hoffmann, AM, Köhler, N, Suárez, I, Preßel, T, Niemann, S, Dreyer, V, Decosterd, LA, Choong, E, Schütz, B, Friesen, I & Rybniker, J 2026, 'Therapeutic drug monitoring-guided treatment of XDR TB with an RpoB I491F mutation-a case report', JAC-antimicrobial resistance, Jg. 8, Nr. 1, S. dlaf251. https://doi.org/10.1093/jacamr/dlaf251
2025
Köhler, N, Otto-Knapp, R, Heinrich, N, Lange, C & Brehm, TT 2025, 'Therapie der Tuberkulose bei Erwachsenen', Deutsche medizinische Wochenschrift (1946), Jg. 150, Nr. 20, S. 1207-1215. https://doi.org/10.1055/a-2612-2364
Pichlo, S, Carballo, PS, Reimann, M, Zielinski, N, Shuaib, YA, Köhler, N, Andres, S, Heyckendorf, J, Kalsdorf, B, Olaru, ID, Salzer, HJF & Lange, C 2025, 'Lipoarabinomannan (LAM) for the diagnosis of tuberculosis from sputum', Journal of infection, Jg. 91, Nr. 6, S. 106662. https://doi.org/10.1016/j.jinf.2025.106662
Pott, H, Weckler, B, Gaffron, S, Martin, R, Maier, D, Alter, P, Biertz, F, Speicher, T, Bertrams, W, Jung, AL, Laakmann, K, Heider, D, Wouters, M, Vogelmeier, CF, Schmeck, B & COSYCONET study group 2025, 'Diffusion capacity and static hyperinflation as markers of disease progression predict 3-year mortality in COPD: Results from COSYCONET', Respirology (Carlton, Vic.), Jg. 30, Nr. 2, S. 134-146. https://doi.org/10.1111/resp.14843
Skevaki, C, Tafo, P, Bahmer, T, Abdo, M, Watz, H, Pedersen, F, Herzmann, C, Rabe, KF, Renz, H, Nockher, WA & ALLIANCE Study Group 2025, 'Differential expression of eicosanoid pathways after whole blood stimulation in asthma patients', The World Allergy Organization journal, Jg. 18, Nr. 4, S. 101047. https://doi.org/10.1016/j.waojou.2025.101047
2024
Fähndrich, S, Herr, C, Teuteberg, S, Alter, P, Söhler, S, Soriano, D, Classen, J, Adams, J, Weinhold, V, Watz, H, Waschki, B, Zeller, T, Eichenlaub, M, Trudzinski, FC, Michels, JD, Omlor, A, Seiler, F, Moneke, I, Biertz, F, Stolz, D, Welte, T, Kauczor, HU, Kahnert, K, Jörres, RA, Vogelmeier, CF, Bals, R & German COSYCONET Cohort 2024, 'Midregional proatrial naturetic peptide (MRproANP) and copeptin (COPAVP) as predictors of all-cause mortality in recently diagnosed mild to moderate COPD-results from COSYCONET', RESPIRATORY RESEARCH , Jg. 25, Nr. 1, S. 56. https://doi.org/10.1186/s12931-024-02690-9
Frantzi, N, Nguyen, XP, Herr, C, Alter, P, Söhler, S, Soriano, D, Watz, H, Waschki, B, Trinkmann, F, Eichenlaub, M, Trudzinski, FC, Michels-Zetsche, JD, Omlor, A, Seiler, F, Moneke, I, Biertz, F, Rohde, G, Stolz, D, Welte, T, Kauczor, HU, Kahnert, K, Jörres, RA, Vogelmeier, CF, Bals, R, Fähndrich, S & German COSYCONET Cohort 2024, 'Statins did not reduce the frequency of exacerbations in individuals with COPD and cardiovascular comorbidities in the COSYCONET cohort', RESPIRATORY RESEARCH , Jg. 25, Nr. 1, S. 207. https://doi.org/10.1186/s12931-024-02822-1
Trudzinski, FC, Jörres, RA, Alter, P, Watz, H, Vogelmeier, CF, Kauczor, H-U, Thangamani, S, Debic, M, Welte, T, Behr, J, Kahnert, K, Bals, R, Herr, C, Heußel, CP, Biederer, J, von Stackelberg, O, Fähndrich, S, Wouters, EFM, Waschki, B, Rabe, KF, Herth, FJF, Palm, V & COSYCONET study group 2024, 'Midregional Proatrial Natriuretic Peptide (MRproANP) is associated with vertebral fractures and low bone density in patients with chronic obstructive pulmonary disease (COPD)', RESPIRATORY RESEARCH , Jg. 25, Nr. 1, S. 274. https://doi.org/10.1186/s12931-024-02902-2
2023
Grychtol, R, Riemann, L, Gaedcke, S, Liu, B, DeLuca, D, Förster, R, Maison, N, Thiele, D, Jakobs, N, Bahmer, T, Meyer, M, Foth, S, Weber, S, Rietschel, E, Rabe, KF, Kopp, MV, von Mutius, E, Dittrich, A-M, Hansen, G & ALLIANCE Study Group 2023, 'Validation of the Asthma Severity Scoring System (ASSESS) in the ALLIANCE Cohort', The Journal of allergy and clinical immunology, Jg. 151, Nr. 6, S. 1525-1535.e4. https://doi.org/10.1016/j.jaci.2023.01.027
Jakwerth, CA, Weckmann, M, Illi, S, Charles, H, Zissler, UM, Oelsner, M, Guerth, F, Omony, J, Nemani, SSP, Grychtol, R, Dittrich, A-M, Skevaki, C, Foth, S, Weber, S, Alejandre Alcazar, MA, van Koningsbruggen-Rietschel, S, Brock, R, Blau, S, Hansen, G, Bahmer, T, Rabe, KF, Brinkmann, F, Kopp, MV, Chaker, AM, Schaub, B, von Mutius, E, Schmidt-Weber, CB & ALLIANCE Study Group 2024, '17q21 Variants Disturb Mucosal Host Defense in Childhood Asthma', American journal of respiratory and critical care medicine. https://doi.org/10.1164/rccm.202305-0934OC
Vierbuchen, T, Agarwal, S, Johnson, JL, Galia, L, Lei, X, Stein, K, Olagnier, D, Gaede, KI, Herzmann, C, Holm, CK, Heine, H, Pai, A, O'Hara Hall, A, Hoebe, K & Fitzgerald, KA 2023, 'The lncRNA LUCAT1 is elevated in inflammatory disease and restrains inflammation by regulating the splicing and stability of NR4A2', PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, Jg. 120, Nr. 1, S. e2213715120. https://doi.org/10.1073/pnas.2213715120
2022
Alter, P, Kahnert, K, Trudzinski, FC, Bals, R, Watz, H, Speicher, T, Söhler, S, Andreas, S, Welte, T, Rabe, KF, Wouters, EFM, Sassmann-Schweda, A, Wirtz, H, Ficker, JH, Vogelmeier, CF & Jörres, RA 2022, 'Disease Progression and Age as Factors Underlying Multimorbidity in Patients with COPD: Results from COSYCONET', International journal of chronic obstructive pulmonary disease, Jg. 17, S. 1703-1713. https://doi.org/10.2147/COPD.S364812
Brandenburg, J, Heyckendorf, J, Marwitz, F, Zehethofer, N, Linnemann, L, Gisch, N, Karaköse, H, Reimann, M, Kranzer, K, Kalsdorf, B, Sanchez-Carballo, P, Weinkauf, M, Scholz, V, Malm, S, Homolka, S, Gaede, KI, Herzmann, C, Schaible, UE, Hölscher, C, Reiling, N & Schwudke, D 2022, 'Tuberculostearic Acid-Containing Phosphatidylinositols as Markers of Bacterial Burden in Tuberculosis', ACS infectious diseases, Jg. 8, Nr. 7, S. 1303-1315. https://doi.org/10.1021/acsinfecdis.2c00075
Freundt, K, Herzmann, C, Biedziak, D, Scheffzük, C, Gaede, KI & Stamme, C 2022, 'Surfactant protein A enhances the degradation of LPS-induced TLR4 in primary alveolar macrophages involving Rab7, β-arrestin2, and mTORC1', INFECTION AND IMMUNITY , Jg. 90, Nr. 2, S. e0025021. https://doi.org/10.1128/IAI.00250-21
Hansen, J, Kolbe, K, König, IR, Scherließ, R, Hellfritzsch, M, Malm, S, Müller-Loennies, S, Zallet, J, Hillemann, D, Wiesmüller, K-H, Herzmann, C, Brandenburg, J & Reiling, N 2022, 'Lipobiotin-capture magnetic bead assay for isolation, enrichment and detection of Mycobacterium tuberculosis from saliva', PLOS ONE, Jg. 17, Nr. 7, S. e0265554. https://doi.org/10.1371/journal.pone.0265554
Kahnert, K, Andreas, S, Kellerer, C, Lutter, JI, Lucke, T, Yildirim, Ö, Lehmann, M, Seissler, J, Behr, J, Frankenberger, M, Bals, R, Watz, H, Welte, T, Trudzinski, FC, Vogelmeier, CF, Alter, P, Jörres, RA, COSYCONET study group & Herzmann, C 2022, 'Reduced decline of lung diffusing capacity in COPD patients with diabetes and metformin treatment', Scientific Reports, Jg. 12, Nr. 1, S. 1435. https://doi.org/10.1038/s41598-022-05276-x
Lüthgen, M, Rüller, S & Herzmann, C 2022, 'Characteristics of the deventilation syndrome in COPD patients treated with non-invasive ventilation: an explorative study', RESPIRATORY RESEARCH , Jg. 23, Nr. 1, S. 13. https://doi.org/10.1186/s12931-022-01924-y
Maison N, Omony J, Illi S, Thiele D, Skevaki C, Dittrich A-M, Bahmer T, Rabe KF, Weckmann M, Happle C, et al. 2022. T2-high asthma phenotypes across lifespan. The European respiratory journal. 60(3). https://doi.org/10.1183/13993003.02288-2021
2020
Luethgen, M, Eggeling, J, Heyckendorf, J, Lange, C, Maier, C, Reimann, M, Sassmann-Schweda, A, Shaikh, R & Herzmann, C 2020, 'Changes in taste and smell as an early marker for COVID-19', INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES , Jg. 99, S. 8-9. https://doi.org/10.1016/j.ijid.2020.07.018
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