Center for Clinical Studies
Das Studienzentrum ist die Schnittstelle zwischen Grundlagenwissenschaft und Patientenversorgung in der Klinik und dem angegliederten Versorgungszentrum. Unsere Expertise liegt in der Planung, Organisation und Durchführung klinischer Studien. Unser Spektrum umfasst translationale Forschungsprojekte in enger Kooperation mit Grundlagenwissenschaftlern, Verbundstudien pneumologischer und infektiologischer Fachverbände und Arzneimittelstudien der pharmazeutischen Industrie.
Unser Fokus sind übertragbare und nicht-übertragbare Erkrankungen der Atemwege. Ein Schwerpunkt ist die klinische Tuberkuloseforschung. Andere Studien betreffen Asthma, Allergie, COPD, Pneumonie, Weaning und andere pneumologische Erkrankungen. Zudem führen wir onkologische Studien durch.
For further information please visit our website sz.fz-borstel.de
- Information for Study Participants
- Information for Doctors
- Information for Scientists
- Information for Sponsors
The Center for Clinical Studies Borstel has three main focuses: translational research, diagnostic or biomolecular investigations on clinical biomaterials and trials according to German Medicine Act (Arzneimittelgesetz, AMG) on therapeutic compounds (phases I - IV). On the on hand, the laboratory infrastructure in Borstel facilitates rapid access to clinical and research laboratories on the campus. On the other hand, our close proximity to the hospital wards and the outpatient department of the “Medizinische Klinik” allows easy recruitment of ambulatory and bed-bound patients for clinical research.
Based on this closely woven connection between basic research, laboratories and patient management, we can offer a wide spectrum of resources and options that can be used for scientific purposes. More details about our facilities and staff can be found here. Subsequently, we offer a wide range of services: planning, layout and conduct of Investigator Initiated Trials, conceptual design of study protocols, consultant services for sponsors, CRO / SMO services for sponsors of industry driven projects, etc. Please visit the following sites for further details.
Know-how
Pre-study
- Conceptual design of clinical trials
- Statistical estimations
- Budget calculations
- Creation of study protocols
- CRF design
- Communication with the Ethics Committee
During the study
- Conduct of clinical trials according to ICH-GCP
- Screening and recruiting of participants
- Professional data acquisition and documentation
- Serious Adverse Events (SAE) and Unexpected Adverse Events (UAE) Management
- Cooperation and support for external monitors and CRAs
Post-study
- Data storage
- Statistical analysis
- Writing of reports
- Support and consultant services for publications
2026
Behrens, E., Köhler, N., Münchow, M., Zielinski, N., Pfaffendorf, C., Grobbel, H.-P., Schaub, D., Reimann, M., Sánchez Carballo, P. M., Kalsdorf, B., Hillemann, D., Kuhns, M., Hofmann-Thiel, S., Hoffmann, H., Decosterd, L. A., Choong, E., Aarnoutse, R., Lange, C. & Wicha, S. G. 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., Nr., 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
Head
Scientific staff
