Once-Daily Tiotropium Respimat Add-On to at Least Ics Maintenance Therapy Reduces Exacerbation Risk in Patients with Uncontrolled Symptomatic Asthma

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 µg 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 FEV 1 , ACQ-7 score and ICS dose (µg) 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 µg 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. Conclusion: Once-daily tiotropium Respimat 5 µg 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.