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Tiotropium as an Add-on Treatment Option for Severe Uncontrolled Asthma in Preschool Patients
Stefan Zielen1, Gianna Reichert1, Helena Donath1
1Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic Fibrosis, University Hospital Frankfurt, Frankfurt, Germany.
Insights
Adding tiotropium to inhaled corticosteroid/long-acting beta-agonist therapy significantly reduced systemic corticosteroid use and exacerbations in young children with severe asthma. This new treatment option shows promise for preschool asthma management.
Area of Science:
- Pediatric Pulmonology
- Asthma Therapeutics
- Pharmacological Interventions
Background:
- Preschool children with asthma experience disproportionately high rates of exacerbations, emergency visits, and hospitalizations despite inhaled corticosteroid (ICS) treatment.
- A prior trial indicated tiotropium's tolerability and potential benefit in reducing asthma-related events in children aged 5 years and younger.
- Severe asthma in toddlers remains a significant clinical challenge, necessitating novel therapeutic strategies.
Purpose of the Study:
- To evaluate the effectiveness of adding tiotropium to ICS/LABA treatment in preschool children with uncontrolled severe asthma.
- To assess the impact of this add-on therapy on systemic corticosteroid prescriptions, physician visits, hospitalizations, and antibiotic use.
- To compare outcomes in treated children with age-, sex-, and season-matched healthy controls.
Main Methods:
- Retrospective analysis of electronic outpatient records from 2017-2019 for children under 6 years old.
- Patients received ICS plus long-acting β2-agonists (LABAs) with tiotropium as add-on therapy for severe, uncontrolled asthma.
- Primary endpoint: comparison of systemic corticosteroid (SCS) prescriptions 6 months before and after initiating ICS/LABA/tiotropium. Secondary endpoints included healthcare utilization and antibiotic prescriptions.
Main Results:
- A significant reduction in SCS courses was observed, from a mean of 2.42 before to 0.74 after adding tiotropium (P<0.001).
- Physician visits decreased from 9.23 to 5.76 per patient (P<0.01), and hospitalizations dropped from 19 to 1 (P<0.01).
- Antibiotic prescriptions also decreased significantly, and hospitalization rates did not differ from healthy controls post-treatment.
Conclusions:
- Adding tiotropium to ICS/LABA represents a novel and effective treatment option for severe preschool asthma.
- The findings suggest a significant reduction in exacerbations and healthcare resource utilization.
- Larger confirmatory studies are warranted to further validate these promising results in pediatric asthma management.
Background:
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.
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