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 asthma

摘要

Background: Once-daily tiotropium Respimat add-on to at least ICS has demon- strated 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. RubaTinAasthma (NCT01257230): once-daily tiotropium Respimat 5 mug or 2.5 mug or placebo Respimat add-on to medium-dose ICS (12-14 years: 200-400 mug budesonide or equivalent [bud or eq]; 14-17 years: 400-800 mug bud or eq) +/- LTRA in adolescents with moderate asthma over 48 weeks; PensieTinA-asthma (NCT01277523): once-daily tiotropium Respimat 5 mug or 2.5 mug or placebo Respimat add-on to high-dose ICS (12-14 years: >400 mug bud or eq; 14-17 years: >800-1600 mug bud or eq) + >1 controller or medium-dose ICS + >2 controllers in adolescents with severe asthma over 12 weeks. AEs included in the analysis were recorded during the treatment period + 30 days. Results: Three hundred and ninety-seven patients received treatment in RubaTinAasthma- (mean age +/- SD = 14.3 +/- 1.7 years) and 392 in PensieTinA-asthma (14.2 +/- 1.7 years). In RubaTinA-asthma and PensieTinA-asthma, respectively: 6.0% and 7.4% of patients were receiving anti-allergic therapies (excluding corticosteroids) at randomisation; 55.2% and 57.4% of patients had a concomitant diagnosis of allergic rhinitis. The frequency of AEs and serious AEs was comparable between treatment groups in the studies, drug-related AEs were rare, and most AEs were mild or moderate in intensity (Table). No deaths occurred. The most commonly reported AEs, by preferred term (Med- DRA version 16.1), were asthma (20.7%), nasopharyngitis (12.6%) and viral respiratory tract infection (8.1%) in RubaTinAasthma , and asthma (11.0%), reduced PEF rate (6.9%) and nasopharyngitis (3.8%) in PensieTinA-asthma. Conclusion: Once-daily tiotropium Respimat add-on to at least ICS maintenance therapy had comparable safety and tolerability with placebo Respimat in adolescent patients with moderate or severe symptomatic asthma. (Table Presented).