Characteristics of children with severe preschool asthma prior to starting the TIPP Study

Stefan Zielen ^1,2* Julia Wosniok ³ Nadine Wollscheid ³ Tanja Nickolay ³ Caroline Grimmel ⁴ David Scheele ² Franziska Sattler ⁵ Freek Prenzel ⁶ Michael Lorenz ⁷ Bianca Prof. Dr. Schaub ⁵ Christiane Lex ⁸ Marcus Dahlheim ⁹ Jordis Trischler ² Helena Donath ² Susanne Lau ¹⁰ Eckard Hamelmann ¹¹ Christian Vogelberg ¹² Michael Gerstlauer ¹³ Martin Wetzke ¹⁴ Ralf Schubert ² Lukas Schollenberger ³ Monika Gappa ⁴

• ¹ Institute for respiratory research, Medaimun GmbH, Frankfurt am Main, Germany
• ² Department of pediatrics, Goethe-University, Frankfurt, Germany
• ³ Interdisciplinary Center for Clinical Studies, University Medical Centre, Johannes Gutenberg University Mainz, Mainz, Rhineland-Palatinate, Germany
• ⁴ Children's Hospital, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany
• ⁵ Pediatric Allergology, Department of Pediatrics, Dr. von Hauner Children's University Hospital, LMU Munich-Member of the German Center for Lung Research-DZL-LMU Munich, Munic, Germany
• ⁶ University of Leipzig, Medical Center, Department of Pediatrics,, Leipzig, Germany
• ⁷ Klinik für Kinder- und Jugendmedizin, Universität Jena,, Jena, Germany
• ⁸ Department for Pediatric Cardiology, Intensive Care and Neonatology, University Medicine, Göttingen, Germany
• ⁹ Kinderlungen-Facharzt, Gemeinschaftspraxis in Mannheim, Mannheim, Germany
• ¹⁰ Department of Respiratory Medicine, Immunology and Critical Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany
• ¹¹ Department of Pediatrics, Children's Center Bethel, University Medicine, Bielefeld, Germany
• ¹² Klinik und Poliklinik für Kinder- und Jugendmedizin, Universitätsklinikum Carl Gustav Carus an der Technischen Universität, Dresden, Germany
• ¹³ Kinderklinik, Universitätsklinikum Augsburg, Augsburg, Germany
• ¹⁴ Clinic for Pediatric Pneumology, Allergology and Neonatology, Center for Pediatrics and Adolescent Medicine, Hannover Medical School, Hannover, Lower Saxony, Germany

Objective: Children with preschool asthma suffer disproportionally more often from severe asthma exacerbations with emergency visits and hospital admissions than school children. However, there are only a few reports on characteristics, hospitalization, phenotypes and symptoms in this age cohort.Patients and Methods: This analysis of an ongoing prospective trial of Tiotropium bromide in preventing severe asthma exacerbations (the TIPP study) assessed baseline characteristics, hospitalizations and symptoms in 100 children with severe preschool asthma. Children aged 1-5 years were analyzed at study enrollment and daily symptoms were recorded by an electronic diary (Pediatric Asthma Caregiver Diary [PACD]) for the following four weeks until randomization.Results: At enrollment, the total number of severe asthma exacerbations, defined as three days systemic steroid use or hospitalization in the last 24 months, was mean (± SD) 5.8 ± 5.7 and the test for respiratory and asthma control in kids (TRACK) was mean 46.9 ± 19.0. Daily recording of symptoms by the PACD revealed that only 7 patients were controlled at randomization, whereas 35 were partially and 58 were uncontrolled according to GINA.Despite protective therapy with inhaled corticosteroids (ICS), most children of this severe asthma cohort were only partially or uncontrolled according to GINA guidelines.