Abstract
Background: Tiotropium Respimat (tioR) add-on to ICS therapy improves lung function in adult patients. Here we examine the efficacy and safety of tioR in adolescents.
Methods: 48-wk Phase III, randomised, double-blind, placebo-controlled, parallel-group trial (NCT01257230) in asthmatic adolescents (12–17 yrs). Inclusion criteria: ≥3-month asthma history; pre-bronchodilator FEV1 ≥60% and ≤90% of predicted; screening ACQ-7 ≥1.5. Patients were randomised to once-daily tioR 5μg, tioR 2.5μg or placebo Respimat (pboR) add-on to ICS (12–14 yrs: 200–400µg; >14 yrs: 400–800µg budesonide or equivalent). Primary end point at wk 24: peak FEV1(0–3h). Additional end points: trough FEV1 and PEFam/pm (wks 24 and 48), and AE data.
Results: 397 patients treated. Mean age: 14.3 yrs (range 11–17 yrs); 65% male; mean FEV1 % predicted at baseline: 82.8. TioR 5µg significantly improved all end points vs pboR at 24 and 48 wks; tioR 2.5µg significantly improved some end points, eg peak FEV1(0–3h) at 24 and 48 wks and trough FEV1 at 48 wks (Table). AEs were comparable across all treatment groups; a small number of drug-related AEs (tioR 5µg=4, tioR 2.5µg=1, pboR=1) and no fatal AEs were reported.
Conclusion: Tiotropium Respimat add-on to ICS significantly improves lung function, has a safety profile comparable with placebo and is well tolerated in adolescent patients with symptomatic asthma.
- © 2014 ERS
