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 (200 – > 800 µg budesonide or equivalent). 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 (µg) were: 56.0 ± 13.1, 2.6 ± 0.7, 1198 ± 539 (PrimoTinA NCT00776984/NCT00772538); 75.1 ± 11.5, 2.2 ± 0.5, 660 ± 213 (MezzoTinA NCT01172808/NCT01172821); 77.7 ± 11.9, 2.1 ± 0.4, 381 ± 78 (GraziaTinA NCT01316380). TioR 5 µg reduced severe asthma exacerbation risk by at least 21% in all three severity cohorts (PrimoTinA: 21% (95% CI 0.62, 1.00; p = 0.034), MezzoTinA: 28% (95% CI 0.45, 1.14; p = 0.164), GraziaTinA: 75% (95% CI 0.03, 2.24; p = 0.216)) 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 may be a beneficial add-on option to reduce current and future exacerbation risk.
Funding: Funding for this trial was provided by Boehringer Ingelheim. Editorial assistance was provided by Complete HealthVizion.
presented at ERS congress 2014