The Effect of Tiotropium in Symptomatic Asthma Despite Low- to Medium-Dose Inhaled Corticosteroids: A Randomized Controlled Trial

BACKGROUND: Tiotropium, a once-daily long-acting anticholinergic bronchodilator, has demonstrated efficacy in patients with asthma who were symptomatic despite treatment with medium- to high-dose inhaled corticosteroids (ICS). OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of once-daily tiotropium Respimat (5 mug or 2.5 mug), compared with placebo Respimat, as add-on therapy to low- to medium-dose ICS for adults with symptomatic asthma. METHODS: A phase III, double-blind, placebo-controlled trial was conducted (NCT01316380). Adults with symptomatic asthma receiving low- to medium-dose ICS (200-400 mug budesonide or equivalent dose) and a pre-bronchodilator forced expiratory volume in 1 second (FEV1) >/=60% and </=90% of predicted normal were randomized to 12 weeks of treatment with once-daily tiotropium Respimat 5 mug or 2.5 mug, or placebo Respimat, as add-on therapy to ICS. The primary endpoint was peak FEV1(0-3h) response. RESULTS: In total, 464 patients were randomized (61% female; mean age 43 years; mean baseline FEV1 78% of predicted normal). After 12 weeks, both tiotropium Respimat doses were superior to placebo (adjusted mean difference from placebo: 5 mug, 128 mL; 2.5 mug, 159 mL; both P < .001). Both doses of tiotropium Respimat were also superior to placebo with regard to the secondary endpoints of adjusted mean trough FEV1 and FEV1 area under the curve(0-3h) responses, and the other endpoints of morning and evening peak expiratory flow. Adverse events were comparable across the treatment groups. CONCLUSIONS: Once-daily tiotropium Respimat add-on therapy to low- to medium-dose ICS in adults with symptomatic asthma is an efficacious bronchodilator, and its safety and tolerability are comparable with those of placebo Respimat.This article is available via Open Access. Please click on the 'Additional Link' above to access the full-text