Abstract
Background: A Phase II trial has shown tiotropium Respimat® (tioR) to be a safe and well-tolerated bronchodilator in patients aged 6-11 years with moderate symptomatic asthma.
Aim: To further assess safety and tolerability of once-daily tioR add-on therapy in a Phase III trial in patients aged 6-11 years with moderate symptomatic asthma.
Methods: This 48-week, Phase III, randomised, double-blind, placebo-controlled, parallel-group study (CanoTinA-asthma®; NCT01634139) was performed in patients aged 6-11 years with moderate symptomatic asthma. Patients received once-daily tioR 5 μg (2 puffs of 2.5 µg) or 2.5 μg (2 puffs of 1.25 µg) or placebo Respimat® (pboR; 2 puffs) as add-on to background therapy (Table). Adverse events (AEs) were recorded and analysed descriptively.
Results: Of 403 patients randomised, 401 were treated, with a mean treatment exposure ± SD of 330.7 ± 39.2 days. The frequency of patients with AEs was similar across all treatment arms, with a low incidence of drug-related and serious AEs (Table); no deaths occurred. The most common AEs were asthma (lower incidence in tioR vs pboR), decreased peak expiratory flow rate, nasopharyngitis and respiratory tract infection (Table).
Conclusion: In patients aged 6-11 years with symptomatic asthma, the safety profile of once-daily tioR as add-on to ICS ± other controllers was similar to that of pboR.
- Copyright ©the authors 2016
