RT Journal Article
SR Electronic
T1 Tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: Lung function and safety
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 4629
VO 42
IS Suppl 57
A1 Kerstjens, H.A.M.
A1 Bleecker, E.
A1 Meltzer, E.
A1 Casale, T.
A1 Pizzichini, E.
A1 Schmidt, O.
A1 Engel, M.
A1 Bour, L.J.
A1 Verkleij, C.B.
A1 Moroni-Zentgraf, P.M.
A1 Bateman, E.D.
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/4629.abstract
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.