Efficacy and safety of tiotropium in partial and uncontrolled preschool asthma (TIPP): a phase III, multicentre, randomised, double-blind, placebo-controlled trial.

Authors

Stefan Zielen, Nadine Wollscheid, Tanja Nickolay, Caroline Grimmel, David Scheele, Franziska Sattler, Freerk Prenzel, Michael Lorenz, Bianca Schaub, Christiane Lex, Franziska Stieglitz, Jordis Trischler, Helena Donath, Susanne Lau, Eckard Hamelmann, Christian Vogelberg, Michael Gerstlauer, Ruth Grychtol, Ralf Schubert, Monika Gappa, Lukas Schollenberger, Julia Wosniok

Published in

EClinicalMedicine. Volume 99. Pages 104172. Epub Sep 04, 2026.

Abstract

Preschool children with asthma are more susceptible to develop acute life-threatening respiratory distress leading to hospital admissions compared to school children and treatment options are limited for this age group. We evaluated the safety and efficacy of tiotropium as add-on therapy to inhaled corticosteroids (ICS) in preschool children with high-risk, partly controlled or uncontrolled asthma.
TIPP was a phase III, prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-group (investigator-initiated) trial conducted at 13 German centres (12 hospitals, one specialised medical practice). Children aged 1-5 years with physician-diagnosed asthma, partly controlled or uncontrolled symptoms despite ICS, and a history of severe exacerbations were randomly assigned to receive once-daily tiotropium (two puffs of 1.25 μg) via Respimat® inhaler or placebo as add-on to ICS therapy over 52 weeks. The primary outcome was time to first severe asthma exacerbation requiring hospitalisation and/or systemic corticosteroid treatment. All randomised participants were included in the intention-to-treat analysis and analysed by treatment received for safety. No primary or safety data were missing; therefore, no imputation was required. The study was registered in the "EU Clinical Trials Registry" (EudraCT 2021-000190-81).
Between February 2022 and March 2025, 100 of the planned 204 children were enrolled, of whom 86 were randomised to tiotropium + ICS (n = 44) or placebo + ICS (n = 42). Mean age was 3.3 years (Standard deviation (SD) 1.3). The primary outcome time to first severe asthma exacerbation did not differ between groups (Hazard ratio (HR): 0.99, 95% confidence interval (CI): 0.51-1.92; p = 0.98). At least one adverse event was reported in 41 (93%) of 44 children in the tiotropium + ICS group and 42 (100%) of 42 children in the placebo + ICS group. 397 adverse events were reported with tiotropium + ICS group and 450 with placebo + ICS group. Tiotropium was well tolerated, and no new safety signal was identified.
Tiotropium did not reduce the risk of a severe asthma exacerbation, but was well tolerated as add-on therapy to ICS in preschool children with high-risk asthma.
German Federal Ministry of Education and Research (01KG2030); study medication provided by Boehringer Ingelheim Pharma GmbH & Co. KG (0205-0546).

PMID:
42733757
Bibliographic data and abstract were imported from PubMed on 14 Sep 2026.

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