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Tiotropium Is Efficacious in 6- to 17-Year-Olds with Asthma, Independent of T2 Phenotype
Stanley J Szefler1, Christian Vogelberg2, Jonathan A Bernstein3
1The Breathing Institute, Children's Hospital of Colorado, Aurora, Colo; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colo.
Insights
Tiotropium add-on therapy is effective for symptomatic pediatric asthma, regardless of allergic markers like IgE or eosinophils. This treatment provides consistent benefits for children aged 6-17 with persistent asthma symptoms.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Pharmacology
Background:
- Symptomatic asthma in children (6-17 years) often involves allergic components.
- Tiotropium add-on therapy shows efficacy and safety in this age group with persistent asthma.
- Understanding the influence of type 2 inflammation markers on treatment response is crucial.
Purpose of the Study:
- To investigate if type 2 status, indicated by serum IgE and blood eosinophils, affects tiotropium add-on therapy response in pediatric asthma.
- To analyze the impact of baseline allergic markers on treatment efficacy in children with symptomatic asthma.
Main Methods:
- Pooled data from four Phase III trials (moderate and severe asthma) involving tiotropium or placebo as add-on therapy to inhaled corticosteroids (ICS).
- Patients aged 6-17 years with symptomatic asthma were analyzed.
- Efficacy outcomes were modeled across a range of baseline IgE levels and blood eosinophil counts.
Main Results:
- Tiotropium improved lung function (FEV1, FEF25-75%, FEV1/FVC) consistently across all levels of baseline IgE and eosinophils.
- Reduced exacerbation risk and improved Asthma Control Questionnaire responder rates with tiotropium were independent of these allergic markers.
- Peak and trough FEV1 improvements were observed with tiotropium treatment.
Conclusions:
- Tiotropium add-on therapy efficacy in pediatric asthma is not influenced by systemic markers of type 2 inflammation (IgE, eosinophils).
- The study supports tiotropium's role in managing symptomatic asthma in children irrespective of their allergic profile.
- Consistent benefits of tiotropium were noted across diverse patient subgroups.
Background:
Tiotropium add-on therapy has demonstrated efficacy and safety in 6- to 17-year-olds with symptomatic asthma despite treatment with inhaled corticosteroids (ICSs), with or without additional controllers. Pediatric patients often have a significant allergic component to their asthma.
Objective:
To explore whether responses to tiotropium add-on were influenced by patients' type 2 status, assessed by serum IgE levels and blood eosinophil counts.
Methods:
Data from 2 phase III trials in symptomatic moderate asthma (CanoTinA-asthma; RubaTinA-asthma) and 2 phase III trials in symptomatic severe asthma (VivaTinA-asthma; PensieTinA-asthma) were pooled by severity. Patients were treated with tiotropium 5 μg, tiotropium 2.5 μg, or placebo (2 puffs once daily via Respimat inhaler), as add-on to ICSs, with or without additional controllers. Modeling of efficacy outcomes was performed over the whole range of baseline IgE levels and blood eosinophil counts, and the treatment effect of the tiotropium doses was presented graphically.
Results:
Improvements with tiotropium in peak FEV1 within 3 hours postdose, trough FEV1, forced expiratory flow at 25% to 75% of the pulmonary volume, and FEV1/forced vital capacity responses were generally consistent across the range of baseline IgE levels and blood eosinophil counts. Risk of exacerbations and improvement in Asthma Control Questionnaire responder rates with tiotropium were also largely independent of IgE levels or eosinophil counts.
Conclusions:
This exploratory analysis suggests that improvements with tiotropium as add-on to ICSs, with or without additional controllers, in 6- to 17-year-olds with symptomatic asthma do not vary according to systemic markers of T2 inflammation, namely, total IgE and blood eosinophil counts.
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