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Protocol development

Asthma Protokolle

Prof. Zielen, our Medical Director, is a globally recognized asthma specialist. He is an active member of the EAACI Working Group on Diagnosis and Treatment of Allergic Asthma, a contributing author of the German guidelines on pediatric asthma, and highly regarded as an expert in bronchial allergen provocation (1–3).

He has developed multiple study protocols and has served as Principal Investigator (PI) or National Coordinator in numerous clinical trials.

1. Effects of tregalizumab on allergen-induced airway responses and airway inflammation in asthmatic patients Phase 2 (allergic asthma in ages ranging from 18 to 65) 

        Sponsor: T-Balance

        EudraCT Number: 2020-000585-41.

2. A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma. TIPP-Study (Asthma Alter 1-5 Jahre)

        Sponsor: Goethe-University (IIT Prof. Zielen)

        EudraCT Number: 2021-000190-81

3. Efficacy and Safety of QGE031 (Ligelizumab) versus Placebo and Omalizumab in patients aged 18-75 years with asthma (Asthma ages 18-75 Jahre)

        Sponsor T-Balance: Novartis GmbH

        EudraCT Number:2020-000585-41.

        A detailed analysis of the study can be found in reference 5. 

References:

1. Medical algorithm: Diagnosis and treatment of house dust mite-driven allergic asthma. Schulze J, Agache I, Eguiluz-Gracia I, Trischler J, Zielen S. Allergy. 2023 May;78(5):1397-1399. doi: 10.1111/all.15654.
2. EAACI position paper on the clinical use of the bronchial allergen challenge: Unmet needs and research priorities. Agache I, Antolin-Amerigo D, … et al. .Zielen S, Eguiluz- Gracia I. Allergy. 2022 Jun;77(6):1667-1684. doi: 10.1111/all. 15203.
3. The late asthmatic reaction is in part independent from the early asthmatic reactions. Zielen S, Alemdar O, Wimmers A, Gronau L, Duecker R, Hutter M, Trischler J, Monchy JG, Schubert R. Int J Mol Sci. 2025 Feb 27;26(5):2088. doi: 10.3390/ijms26052088.
4. Dual role of microRNA-146a in experimental inflammation in human pulmonary epithelial and immune cells and expression in inflammatory lung diseases. Gronau L, Duecker RP, Jerkic SP, Eickmeier O, Trischler J, Chiocchetti AG, Blumchen K, Zielen S, Schubert R. Int J Mol Sci. 2024 Jul 13;25(14):7686. doi: 10.3390/ijms25147686.
5. Ligelizumab treatment for severe asthma: learnings from the clinical development programme. Trischler J, Bottoli I, Janocha R, Heusser C, Jaumont X, Lowe P, Gautier A, Pethe A, Woessner R, Zerwes HG, Zielen S. Clin Transl Immunology. 2021 Mar 15;10(3):e1255. doi: 10.1002/cti2.1255.