Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598379
Posterbegehung – Sektion Klinische Pneumologie
Asthma bronchiale – Stephanie Korn/Mainz, Christian Geßner/Leipzig
Georg Thieme Verlag KG Stuttgart · New York

Efficacy of tiotropium in patients aged 6 – 17 years with severe symptomatic asthma

E Hamelmann
1  Department of Pediatrics, Evangelisches Krankenhaus Bielefeld and Allergy Center of the Ruhr University Bochum
,
SJ Szefler
2  Department of Pediatrics, Children's Hospital Colorado and the University of Colorado School of Medicine
,
JA Bernstein
3  Uc Allergy Clinical Research Center, University of Cincinnati College of Medicine
,
K Murphy
4  Boys Town National Research Hospital, Boys Town Ne
,
G El Azzi
5  Boehringer Ingelheim Pharma GmbH & Co. KG
,
M Engel
5  Boehringer Ingelheim Pharma GmbH & Co. KG
,
P Moroni-Zentgraf
5  Boehringer Ingelheim Pharma GmbH & Co. KG
,
R Sigmund
5  Boehringer Ingelheim Pharma GmbH & Co. KG
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

 

Purpose:

We studied tiotropium Respimat® (tioR) add-on to ICS plus other controller medications in 6 – 17 year-olds with severe symptomatic asthma.

Methods:

Pooled analysis was performed of two 12-week studies comparing tioR 2.5 µg (2 puffs, 1.25 µg) and 5 µg (2 puffs, 2.5 µg) with placebo Respimat® (VivaTinA-asthma, NCT01634152, 6 – 11 year-olds, and PensieTinA-asthma, NCT01277523, 12 – 17 year-olds). The primary endpoint was peak FEV1(0 – 3h) change from baseline at 12 weeks; secondary endpoints included trough FEV1, ACQ, rescue medication use and exacerbations.

Results:

792 subjects were randomized. TioR improved peak FEV1(0 – 3h) versus placebo in the pooled analysis: tioR 2.5 µg 74 mL (95% CI 8, 140; P= 0.027), tioR 5 µg 117 mL (95% CI 51, 183, P= 0.0005). Separate study data: 6 – 11 year-olds tioR 2.5 µg 35 mL (95% CI -28, 99; P= 0.272), tioR 5 µg 139 mL (95% CI 75, 203, P< 0.0001); 12 – 17 year-olds tioR 2.5 µg 111 mL (95% CI 2, 220; P= 0.046), tioR 5 µg 90 mL (95% CI -19, 198, P= 0.104). Trough FEV1 versus placebo: pooled analysis tioR 2.5 µg 64 mL (95% CI -3, 132; P= 0.062), tioR 5 µg 71 mL (95% CI 3, 139, P= 0.040); 6 – 11 year-olds tioR 2.5 µg 18 mL (95% CI -48, 85; P= 0.590), tioR 5 µg 87 mL (95% CI 19, 154, P= 0.012); 12 – 17 year-olds tioR 2.5 µg 115 mL (95% CI -0.0, 231; P= 0.051), tioR 5 µg 54 mL (95% CI -61, 168, P= 0.361). In the pooled analysis, time to first exacerbation was significantly longer with tioR than placebo (tioR 2.5 µg P= 0.009, tioR 5 µg P= 0.029). Other secondary endpoints were not significantly different between groups. Adverse events were similar between groups.

Conclusions:

In the pooled analysis, tiotropium Respimat® add-on to ICS plus controller medication improved lung function and time to first exacerbation compared with placebo in 6 – 17 year-olds with severe symptomatic asthma.

Clinical implications:

Adding tiotropium Respimat® to existing controller medication may improve lung function and reduce exacerbations in children with severe symptomatic asthma.

Content already presented at CHEST congress 2016