LATE-BREAKING ABSTRACT: Once-daily tiotropium Respimat®add-on therapy improves lung function in children with moderate symptomatic asthma
| Autor: | Eckard Hamelmann, Helen Finnigan, Petra Moroni-Zentgraf, Christian Vogelberg, Olaf Schmidt, Michael Engel, István Laki, Georges El Azzi, Mark Vandewalker |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Respimat business.industry Area under the curve Placebo medicine.disease respiratory tract diseases Surgery 03 medical and health sciences FEV1/FVC ratio 0302 clinical medicine 030228 respiratory system Tolerability Maintenance therapy Internal medicine Clinical endpoint Medicine 030212 general & internal medicine business Asthma |
| Zdroj: | 7.2 Paediatric Asthma and Allergy. |
| DOI: | 10.1183/13993003.congress-2016.pa4398 |
| Popis: | Background: Tiotropium Respimat® (tioR) has been shown to improve lung function in a Phase II study in children with moderate symptomatic asthma. Aim: To assess the efficacy of once-daily tioR add-on therapy in a Phase III trial in patients (pts) 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 pts aged 6-11 years with moderate symptomatic asthma. Pts received once-daily tioR 5 μg (2 puffs, 2.5 µg) or 2.5 μg (2 puffs, 1.25 µg) or placebo Respimat® (pboR; 2 puffs) as add-on to background therapy (Table). Primary end point: peak FEV1 within 3 hours post-dosing (FEV1(0-3h)); secondary end points included trough FEV1 (key end point), FEV1 area under the curve (AUC)(0-3h) and peak FVC(0-3h), all measured as response (change from baseline) at Week 24. Results: Of 403 pts randomised, 401 were treated. Baseline demographics and disease characteristics were balanced between treatment groups. TioR 5 µg and 2.5 µg provided statistically significant improvements in lung function versus pboR at Week 24 (Table). The safety and tolerability of tioR were comparable with those of pboR. Conclusion: In pts aged 6-11 years with moderate symptomatic asthma, once-daily tioR add-on to ICS with or without other maintenance therapy improves lung function compared with pboR. |
| Databáze: | OpenAIRE |
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