P148 Once-daily tiotropium Respimat® add-on to at least ICS maintenance therapy reduces exacerbation risk in patients with uncontrolled symptomatic asthma: Abstract P148 Table 1

Abstract

Background: A reduction in asthma exacerbation risk may provide improvements in clinical burden, patient experience and healthcare costs. In Phase III trials, once-daily tiotropium Respimat (tioR) add-on to at least ICS improved lung function in symptomatic asthma patients. We investigated exacerbation risk in each trial. Methods: Five Phase III double-blind, placebo-controlled, parallel-group trials in patients with symptomatic asthma. Patients received tioR 5 {micro}g or placebo Respimat (pboR) as add-on to at least ICS maintenance therapy (Table). Pre-planned co-primary or secondary end points: time to first severe exacerbation; time to any asthma worsening. Results: Mean baseline % of predicted FEV1, ACQ-7 score and ICS dose ({micro}g) were: 56.0{+/-}13.1, 2.6{+/-}0.7, 1198{+/-}539 (PrimoTinA); 75.1{+/-}11.5, 2.2{+/-}0.5, 660{+/-}213 (MezzoTinA); 77.7{+/-}11.9, 2.1{+/-}0.4, 381{+/-}78 (GraziaTinA). TioR 5 {micro}g reduced severe asthma exacerbation risk by at least 21% in all three severity cohorts (Table) and asthma worsening risk vs pboR in all trials, with a statistically significant reduction in PrimoTinA. F1000"> WIDTH=200 HEIGHT=151 SRC="/small/852984_halpin_table.gif" ALT="Figure 1000"> View larger version (35K): F1000590532F1000 Conclusion: Once-daily tiotropium Respimat 5 {micro}g add-on to at least ICS maintenance therapy consistently reduced exacerbations across asthma severities and so may be a beneficial add-on option to reduce current and future exacerbation risk.