Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598380
Posterbegehung – Sektion Klinische Pneumologie
Asthma bronchiale – Stephanie Korn/Mainz, Christian Geßner/Leipzig
Georg Thieme Verlag KG Stuttgart · New York

Safety of tiotropium Respimat add-on therapy in patients aged 6 – 17 years with symptomatic asthma

C Vogelberg
1  Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Carl Gustav Carus
,
SJ Szefler
2  Department of Pediatrics, Children's Hospital of Colorado and the University of Colorado Denver School of Medicine
,
E Hamelmann
3  Evangelisches Krankenhaus Bielefeld and Allergy Center of the Ruhr University, Bochum
,
A Boner
4  Pediatric Department, University of Verona
,
P Moroni-Zentgraf
5  Ta Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG
,
M Engel
5  Ta Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG
,
G El Azzi
5  Ta Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG
,
H Finnigan
6  Biostatistics and Data Sciences, Boehringer Ingelheim Ltd
,
M Vandewalker
7  Clinical Research of the Ozarks
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

 

Background:

Two Phase II trials have shown tiotropium Respimat® (tioR) to be a well-tolerated bronchodilator in patients (pts) aged 12 – 171 and 6 – 112 years (yrs) with symptomatic asthma.

Aim:

To further assess safety and tolerability of once-daily (QD) tioR add-on therapy in Phase III trials in pts aged 6 – 17yrs with symptomatic asthma.

Methods:

Data analysed from 3 completed Phase III, randomised, double-blind, placebo-controlled, parallel-group trials: VivaTinA (NCT01634152), 12-week trial, pts aged 6 – 11yrs; PensieTinA (NCT01257230), 12-week trial, pts aged 12 – 17yrs; RubaTinA (NCT01277523), 48-week trial, pts aged 12 – 17yrs. Pts received QD tioR 5 µg (2 puffs, 2.5 µg), QD tioR 2.5 µg (2 puffs, 1.25 µg) or QD placebo Respimat® (pboR; 2 puffs) as add-on to background therapy. Adverse events (AEs) were recorded and analysed descriptively by age: 6 – 11yrs; 12 – 17yrs.

Results:

1189 pts were treated: 6 – 11yrs, n = 400; 12 – 17yrs, n = 789. The frequency of pts with AEs was similar across all treatment arms, with a low incidence of drug-related and serious AEs; asthma and decreased peak expiratory flow rate were the most common AEs. No deaths occurred.

Conclusion:

The AE profile and AE incidences were similar between tioR 5 µg, tioR 2.5 µg and pboR, as add-on to ICS ± other controllers, in pts aged 6 – 17yrs with symptomatic asthma.

References:

[1] Vogelberg et al. Respir Med 2014;108:1268 – 76

[2] Vogelberg et al. Respir Res 2015;16:20

Content already presented at ERS congress 2016