PT  - JOURNAL ARTICLE
AU  - Halpin, DMG
AU  - Paggiaro, P
AU  - Bleecker, E
AU  - Engel, M
AU  - Moroni-Zentgraf, P
AU  - Schmidt, H
AU  - Kerstjens, HAM
TI  - P255 Once-daily Tiotropium Respimat® Add-on To At Least Ics Maintenance Therapy Reduces Exacerbation Risk In Patients With Uncontrolled Symptomatic Asthma
AID  - 10.1136/thoraxjnl-2014-206260.383
DP  - 2014 Dec 01
TA  - Thorax
PG  - A189--A189
VI  - 69
IP  - Suppl 2
4099  - http://thorax.bmj.com/content/69/Suppl_2/A189.1.short
4100  - http://thorax.bmj.com/content/69/Suppl_2/A189.1.full
SO  - Thorax2014 Dec 01; 69
AB  - 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 (delivered via the Respimat® SoftMist™ inhaler) added on to at least inhaled corticosteroids (ICS) improved lung function in patients with symptomatic asthma. 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 tiotropium Respimat® 5 µg or placebo as add-on to at least ICS maintenance therapy (Table). Pre-planned co-primary or secondary end points were time to first severe exacerbation and time to any asthma worsening. Results Mean baseline% of predicted forced expiratory volume in 1 second, seven-question Asthma Control Questionnaire score and ICS dose (µg) were: 56.0 ± 13.1, 2.6 ± 0.7, 1198 ± 539 (PrimoTinA-asthma®); 75.1 ± 11.5, 2.2 ± 0.5, 660 ± 213 (MezzoTinA-asthma®); 77.7 ± 11.9, 2.1 ± 0.4, 381 ± 78 (GraziaTinA-asthma®). Tiotropium Respimat® 5 µg reduced severe asthma exacerbation risk by at least 21% in all three severity cohorts (Table) and asthma worsening risk versus placebo in all trials, with a statistically significant reduction in the PrimoTinA-asthma® trial. 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.