Tiotropium as an Add-on Treatment Option for Severe Uncontrolled Asthma in Preschool Patients

Abstract

Stefan Zielen,1 Gianna Reichert,1 Helena Donath,1 Jordis Trischler,1 Johannes Schulze,1 Olaf Eickmeier,1 Martin Eckrich,2 Katharina Blumchen1 1Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic Fibrosis, University Hospital Frankfurt, Frankfurt, Germany; 2Group Practice Dres. Med. Martin Eckrich and Matthias Gründler, Offenbach am Main, GermanyCorrespondence: Stefan ZielenDepartment for Children and Adolescents, Division of Allergology, Pulmonology and Cystic Fibrosis, University Hospital Frankfurt, Theodor-Stern-Kai 7, Frankfurt 60590, GermanyTel [phone]Email [email protected]: Toddlers with asthma suffer disproportionally more than school-aged children from exacerbations with emergency visits and hospital admissions despite inhaled corticosteroid (ICS) treatment. A recent trial for children ≤ 5 years showed tolerability of tiotropium and potential to reduce asthma-related events.Methods: We conducted a retrospective analysis of electronic outpatient records (2017‒2019) of children < 6 years treated with ICS plus long-acting β2-agonists (LABAs) plus tiotropium as an add-on for uncontrolled severe asthma. The primary endpoint was a comparison of systemic corticosteroid (SCS) prescriptions 6 months before and after ICS/LABA/tiotropium start. Secondary endpoints included physician visits, hospitalisations and antibiotic prescriptions. We compared outcomes with children without asthma matched for age, sex, season and screening date.Results: Compared with a mean 2.42 (95% CI: 1.75, 3.36) SCS courses per patient within 6 months prior to ICS/LABA/tiotropium, 0.74 (95% CI: 0.25, 1.08) SCS courses per patient were prescribed within 6 months after starting ICS/LABA/tiotropium (P< 0.001). Physician visits dropped from 9.23 (95% CI: 7.15, 12.72) to 5.76 (95% CI: 3.10, 7.70) per patient (P< 0.01). Nineteen hospitalisations were recorded 6 months before ICS/LABA/tiotropium compared with one hospitalisation after (P< 0.01). A mean 1.79 antibiotic courses (95% CI: 1.22, 2.23) per patient were prescribed before ICS/LABA/tiotropium compared with 0.74 (95% CI: 0.22, 1.00) after ICS/LABA/tiotropium (P< 0.001). Hospitalisation rates for patients at observation end were not statistically different from healthy controls before/after matching.Interpretation: Our retrospective study showed that adding tiotropium to ICS/LABA is a new treatment option for patients with severe preschool asthma; however, larger confirmatory studies are needed.Keywords: preschool asthma, severe uncontrolled asthma, tiotropium, inhaled steroids, long-acting β2-agonists, LABAs

Keywords

• preschool asthma
• severe uncontrolled asthma
• tiotropium
• inhaled steroids
• long-acting β2-agonists (laba)s