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A randomised dose-ranging study of tiotropium Respimat® in children with symptomatic asthma despite inhaled
Insights
Tiotropium Respimat® effectively improved lung function in symptomatic pediatric asthma patients when added to standard treatment. The add-on therapy demonstrated comparable safety and tolerability to placebo, offering a promising option for managing childhood asthma.
Area of Science:
- Pediatric pulmonology
- Pharmacological interventions for respiratory diseases
- Clinical trial research
Background:
- Many children with asthma experience persistent symptoms despite inhaled corticosteroid therapy.
- This leads to significant morbidity, reduced quality of life, and increased healthcare utilization.
- Current treatment limitations necessitate exploring novel therapeutic strategies for pediatric asthma.
Purpose of the Study:
- To evaluate the efficacy, safety, and tolerability of once-daily tiotropium Respimat® as an add-on therapy.
- The study assessed three different doses (5 μg, 2.5 μg, 1.25 μg) in children aged 6-11 years with symptomatic asthma.
- The add-on therapy was combined with medium-dose inhaled corticosteroids, with or without a leukotriene modifier.
Main Methods:
- A Phase II, double-blind, placebo-controlled, incomplete-crossover, dose-ranging study was conducted.
- Patients were randomized to receive three of four treatments: tiotropium Respimat® (5 μg, 2.5 μg, 1.25 μg) or placebo Respimat®, administered in the evening.
- The treatment duration was 12 weeks, comprising three 4-week periods.
Main Results:
- All tested doses of tiotropium Respimat® (5 μg, 2.5 μg, 1.25 μg) significantly improved peak forced expiratory volume in 1 second (FEV1) compared to placebo.
- The adjusted mean FEV1 responses were 272 mL, 290 mL, and 261 mL for the respective tiotropium doses, versus 185 mL for placebo (p < 0.0011 for all).
- Safety and tolerability profiles were similar across all tiotropium doses and placebo, with no serious adverse events or discontinuations due to adverse events.
Conclusions:
- Tiotropium Respimat® as an add-on therapy demonstrated significant efficacy in improving lung function in pediatric patients with symptomatic asthma.
- The safety and tolerability of tiotropium Respimat® were comparable to placebo when used in conjunction with inhaled corticosteroids.
- This study supports tiotropium Respimat® as a potentially valuable treatment option for children with inadequately controlled asthma.
Background:
A considerable number of children with asthma remain symptomatic despite treatment with inhaled corticosteroids, resulting in significant morbidity, reduced quality of life, increased healthcare costs and lost school days. The aim of our study was to assess the efficacy, safety and tolerability of once-daily tiotropium Respimat® 5 μg, 2.5 μg and 1.25 μg add-on to medium-dose inhaled corticosteroids, with or without a leukotriene modifier, in children aged 6-11 years with symptomatic asthma.
Methods:
In this Phase II, double-blind, placebo-controlled, incomplete-crossover, dose-ranging study, patients were randomised to receive three of the four treatments evaluated: once-daily tiotropium Respimat® 5 μg, 2.5 μg or 1.25 μg or placebo Respimat®, in the evening during the 12-week (three × 4-week) treatment period.
Results:
In total, 76, 74, 75 and 76 patients aged 6-11 years received tiotropium Respimat® 5 μg, 2.5 μg, 1.25 μg and placebo Respimat®, respectively. For the primary end point (peak forced expiratory volume in 1 second measured within 3 hours post-dosing), the adjusted mean responses with tiotropium Respimat® 5 μg (272 mL), 2.5 μg (290 mL) and 1.25 μg (261 mL) were significantly greater than with placebo Respimat® (185 mL; p = 0.0002, p < 0.0001 and p = 0.0011, respectively). The safety and tolerability of all doses of tiotropium Respimat® were comparable with those of placebo Respimat®, with no serious adverse events and no events leading to discontinuation.
Conclusions:
Tiotropium Respimat® add-on to medium-dose inhaled corticosteroids, with or without a leukotriene modifier, was efficacious in paediatric patients with symptomatic asthma and had comparable safety and tolerability with placebo Respimat®.
Trial Registration:
ClinicalTrials.gov identifier NCT01383499.
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