Selected Publications: Early-phase Clinical Trials
- Carstensen-Aurèche S, Litzenburger T, De Sousa D, Sailer R, Benediktus E, Delic D, Müller F, Müller M, Hohlfeld JM. Safety, tolerability, pharmacokinetics and pharmacodynamics of the spleen tyrosine kinase inhibitor BI 894416 in healthy volunteers and patients with asthma. Br J Pharmacol. 2026 Feb 6. doi: 10.1111/bph.70329. Epub ahead of print. PMID: 41652821.
- Hohlfeld JM, Badorrek P, Breuer O, Hanrott K, Kricker J, Parnham MJ, Norris V. Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial. Pulm Pharmacol Ther. 2025 Sep;90:102365. doi: 10.1016/j.pupt.2025.102365. Epub 2025 Jun 3. PMID: 40466859.
- Kayser T, Smulders R, Kusawake T, Wambre E, Chichili GR, Blauwet MB, Spence A, Patton M, Tabash R, DeBerg HA, Khosa S, Badorrek P, Hohlfeld JM, Ferslew BC. Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites. J Allergy Clin Immunol Glob. 2025 Jan 7;4(2):100404. doi: 10.1016/j.jacig.2025.100404. PMID: 40008094; PMCID: PMC11851213.
- Cunnion K, Goss J, Hair P, Dell L, Roberson D, Thienel U, Müller M, Carstensen-Aurèche S, Badorrek P, Holz O, Hohlfeld JM. RLS-0071, a novel anti-inflammatory agent, significantly reduced inflammatory biomarkers in a randomised human evaluation of mechanisms and safety study. ERJ Open Res. 2024 Sep 16;10(4):01006-2023. doi: 10.1183/23120541.01006-2023. PMID: 39286057; PMCID: PMC11403592.
- Mole S, Harry A, Fowler A, Hotee S, Warburton J, Waite S, Beerahee M, Behm DJ, Badorrek P, Müller M, Faulenbach C, Lazaar AL, Hohlfeld JM. Investigating the effect of TRPV4 inhibition on pulmonary-vascular barrier permeability following segmental endotoxin challenge. Pulm Pharmacol Ther. 2020 Oct;64:101977. doi: 10.1016/j.pupt.2020.101977.
Selected Publications: Bronchoscopy and Challenge Studies
- Gress C, Müller M, Hohlfeld JM. Proteomic profiling of bronchoalveolar lavage following human segmental endotoxin challenge-a potential exacerbation model. Sci Rep. 2026 Feb 12;16(1):6145. doi: 10.1038/s41598-026-39528-x. PMID: 41680454; PMCID: PMC12902028.
- Gress C, Litzenburger T, Schmid R, Xiao K, Heissig F, Muller M, Gupta A, Hohlfeld JM. Transcriptomic characterization of the human segmental endotoxin challenge model. Sci Rep. 2024 Jan 19;14(1):1721. doi: 10.1038/s41598-024-51547-0. PMID: 38242945; PMCID: PMC10798985.
- Sadiq MW, Holz O, Ellinghusen BD, Faulenbach C, Müller M, Badorrek P, Eriksson UG, Fridén M, Stomilovic S, Lundqvist AJ, Hohlfeld JM. Lung pharmacokinetics of inhaled and systemic drugs: A clinical evaluation. Br J Pharmacol. 2021 Nov;178(22):4440-4451. doi: 10.1111/bph.15621. Epub 2021 Aug 11. PMID: 34250588.
Selected Publications: Pulmonary Imaging
- Kern AL, Park DH, Fuge J, Hohlfeld JM, Wacker F, Hoeper MM, Olsson KM, Vogel-Claussen J. Loss of pulmonary capillaries in idiopathic pulmonary arterial hypertension with low diffusion capacity is accompanied by early diffuse emphysema detected by 129Xe MRI. Eur Radiol. 2025 Jun;35(6):3010-3020. doi: 10.1007/s00330-024-11209-1. Epub 2024 Dec 8. PMID: 39645621; PMCID: PMC12081569.
- Voskrebenzev A, Kaireit TF, Klimeš F, Pöhler GH, Behrendt L, Biller H, Berschneider K, Wacker F, Welte T, Hohlfeld JM, Vogel-Claussen J. PREFUL MRI Depicts Dual Bronchodilator Changes in COPD: A Retrospective Analysis of a Randomized Controlled Trial. Radiol Cardiothorac Imaging. 2022 Apr 21;4(2):e210147. doi: 10.1148/ryct.210147. PMID: 35506142; PMCID: PMC9059092.
- Kern AL, Biller H, Klimeš F, Voskrebenzev A, Gutberlet M, Renne J, Müller M, Holz O, Wacker F, Hohlfeld JM, Vogel-Claussen J. Noninvasive Monitoring of the Response of Human Lungs to Low-Dose Lipopolysaccharide Inhalation Challenge Using MRI: A Feasibility Study. J Magn Reson Imaging. 2020 Jun;51(6):1669-1676. doi: 10.1002/jmri.27000. Epub 2019 Nov 15. PMID: 31729119.
Selected Publications: Biomarker Development and Analysis
- Holz O, van Vorstenbosch R, Guenther F, Schuchardt S, Trinkmann F, van Schooten FJ, Smolinska A, Hohlfeld JM. Changes of breath volatile organic compounds in healthy volunteers following segmental and inhalation endotoxin challenge. J Breath Res. 2022 May 3;16(3). doi: 10.1088/1752-7163/ac6359. PMID: 35366648.
- Larsson P, Holz O, Koster G, Postle A, Olin AC, Hohlfeld JM. Exhaled breath particles as a novel tool to study lipid composition of epithelial lining fluid from the distal lung. BMC Pulm Med. 2023 Nov 3;23(1):423. doi: 10.1186/s12890-023-02718-8. PMID: 37924084; PMCID: PMC10623716.
- Holz O, Müller M, Carstensen S, Olin AC, Hohlfeld JM. Inflammatory cytokines can be monitored in exhaled breath particles following segmental and inhalation endotoxin challenge in healthy volunteers. Sci Rep. 2022 Apr 4;12(1):5620. doi: 10.1038/s41598-022-09399-z. PMID: 35379863; PMCID: PMC8979977.
- Carstensen S, Holz O, Hohlfeld JM, Müller M. (2021). Quantitative analysis of endotoxin-induced inflammation in human lung cells by Chipcytometry. Cytometry A. 2021 Apr 15. doi: 10.1002/cyto.a.24352. [Epub ahead of print]. PMID: 33860615
Selected Publications: Non-clinical Studies
- Prasse A, Binder H, Schupp JC, Kayser G, Bargagli E, Jaeger B, Hess M, Rittinghausen S, Vuga L, Lynn H, Violette S, Jung B, Quast K, Vanaudenaerde B, Xu Y, Hohlfeld JM, Krug N, Herazo-Maya JD, Rottoli P, Wuyts WA, Kaminski N. BAL Cell Gene Expression Is Indicative of Outcome and Airway Basal Cell Involvement in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2019 Mar 1;199(5):622-630. doi: 10.1164/rccm.201712-2551OC. PMID: 30141961; PMCID: PMC6396865.
- Jaeger B, Schupp JC, Plappert L, Terwolbeck O, Artysh N, Kayser G, Engelhard P, Adams TS, Zweigerdt R, Kempf H, Lienenklaus S, Garrels W, Nazarenko I, Jonigk D, Wygrecka M, Klatt D, Schambach A, Kaminski N, Prasse A. Airway basal cells show a dedifferentiated KRT17highPhenotype and promote fibrosis in idiopathic pulmonary fibrosis. Nat Commun. 2022 Sep 26;13(1):5637. doi: 10.1038/s41467-022-33193-0. PMID: 36163190; PMCID: PMC9513076.
- Derlin T, Jaeger B, Jonigk D, Apel RM, Freise J, Shin HO, Weiberg D, Warnecke G, Ross TL, Wester HJ, Seeliger B, Welte T, Bengel FM, Prasse A. Clinical Molecular Imaging of Pulmonary CXCR4 Expression to Predict Outcome of Pirfenidone Treatment in Idiopathic Pulmonary Fibrosis. Chest. 2021 Mar;159(3):1094-1106. doi: 10.1016/j.chest.2020.08.2043. Epub 2020 Aug 19. PMID: 32822674.
- Jäger B, Seeliger B, Terwolbeck O, Warnecke G, Welte T, Müller M, Bode C, Prasse A. The NLRP3-Inflammasome-Caspase-1 Pathway Is Upregulated in Idiopathic Pulmonary Fibrosis and Acute Exacerbations and Is Inducible by Apoptotic A549 Cells. Front Immunol. 2021 Apr 23;12:642855. doi: 10.3389/fimmu.2021.642855. PMID: 33968032; PMCID: PMC8104027.
- Huppertz C, Jäger B, Wieczorek G, Engelhard P, Oliver SJ, Bauernfeind FG, Littlewood-Evans A, Welte T, Hornung V, Prasse A. The NLRP3 inflammasome pathway is activated in sarcoidosis and involved in granuloma formation. Eur Respir J. 2020 Mar 26;55(3):1900119. doi: 10.1183/13993003.00119-2019. PMID: 31949113.
- Prasse A, Probst C, Bargagli E, Zissel G, Toews GB, Flaherty KR, Olschewski M, Rottoli P, Müller-Quernheim J. Serum CC-chemokine ligand 18 concentration predicts outcome in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2009 Apr 15;179(8):717-23. doi: 10.1164/rccm.200808-1201OC. Epub 2009 Jan 29. PMID: 19179488.
- Prasse A, Pechkovsky DV, Toews GB, Jungraithmayr W, Kollert F, Goldmann T, Vollmer E, Müller-Quernheim J, Zissel G. A vicious circle of alveolar macrophages and fibroblasts perpetuates pulmonary fibrosis via CCL18. Am J Respir Crit Care Med. 2006 Apr 1;173(7):781-92. doi: 10.1164/rccm.200509-1518OC. Epub 2006 Jan 13. PMID: 16415274.
Fraunhofer Institute for Toxicology and Experimental Medicine