Safety and tolerability of once-daily tiotropium Respimat® add-on to at least inhaled corticosteroid maintenance therapy in adolescent patients with moderate or severe symptomatic…
E Beck, R Dahl, SJ Szefler, J Bernstein, M Vandewalker, M Engel, P Moroni-Zentgraf, A Unseld, E Hamelmann · Pneumologie · 2016 · Heft 02
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Zusammenfassung
Background: Once-daily tiotropium Respimat® add-on to at least ICS has demonstrated efficacy, safety and tolerability in adult patients across severities of asthma. We assess the safety and tolerability of once-daily tiotropium Respimat® in adolescent patients aged 12 – 17 years with moderate or severe symptomatic asthma. Method: Two Phase III, randomised, double-blind, parallel-group trials. RubaTinA-asthma® (NCT01257230): once-daily tiotropium Respimat® 5 µg or 2.5 µg or placebo Respimat® add-on to medium-dose ICS (12 – 14 years: 200 – 400 µg budesonide or equivalent [bud or eq]; 14 – 17 years: 400 – 800 µg bu…
