PT  - JOURNAL ARTICLE
AU  - Kerstjens, H.A.M.
AU  - Bleecker, E.
AU  - Meltzer, E.
AU  - Casale, T.
AU  - Pizzichini, E.
AU  - Schmidt, O.
AU  - Engel, M.
AU  - Bour, L.J.
AU  - Verkleij, C.B.
AU  - Moroni-Zentgraf, P.M.
AU  - Bateman, E.D.
TI  - Tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: Lung function and safety
DP  - 2013 Sep 01
TA  - European Respiratory Journal
PG  - 4629
VI  - 42
IP  - Suppl 57
4099  - http://erj.ersjournals.com/content/42/Suppl_57/4629.short
4100  - http://erj.ersjournals.com/content/42/Suppl_57/4629.full
SO  - Eur Respir J2013 Sep 01; 42
AB  - Background: Asthma is not controlled in some patients, despite using medium-dose ICS.Methods: Two identical Phase III, randomised, double-blind, double-dummy, placebo (pbo)-controlled, parallel-group trials (NCT01172808/821) assessed tiotropium (tio) efficacy/safety. Patients with symptomatic asthma and pre-bronchodilator FEV1 60-90% predicted, using medium-dose ICS (400-800µg budesonide equivalent), were randomised to once-daily tio 5µg or 2.5µg (via Respimat® Soft Mist™ Inhaler), salmeterol (sal, active comparator without inferential analysis) or pbo. Other LABAs were not permitted. Pre-specified co-primary end points included peak FEV1(0-3h) and trough FEV1 response at 24 wks.Results: Baseline characteristics were similar between trials/treatment groups in 2103 randomised patients (2100 treated); mean post-bronchodilator FEV1 88.8% predicted. Both tio doses showed significant improvements vs pbo: mean change from baseline in peak FEV1(0-3h) at 24 wks: 236 mL (tio 2.5µg)/198 mL (tio 5µg) greater than pbo in trial 1 (sal 213 mL); 211 mL (tio 2.5µg) or 169 mL (tio 5µg) greater in trial 2 (all p<0.0001) (sal 176 mL). FEV1 trough response at 24 wks: 185 mL (tio 2.5µg)/152 mL (tio 5µg) greater in trial 1 (sal 123 mL); 176 mL (tio 2.5µg)/133 mL (tio 5µg) greater in trial 2 (all p<0.0001) (sal 106 mL). Discontinuation due to adverse events (AEs): pbo, 2.5%; tio 2.5µg, 1.2%; tio 5µg, 1.9%, sal, 1.8%. No fatal events. AEs balanced across treatment groups.Conclusion: In patients with symptomatic asthma and airflow limitation despite medium-dose ICS, addition of once-daily tiotropium provides sustained bronchodilation (efficacy comparable to sal) and is well tolerated.