Tiotropium improves lung function in symptomatic asthma patients on ICS/LABA

New England Journal of MedicineSep 3 2012

Data from the PrimoTinA-asthma^TM Phase III studies presented for the first time today at the 2012 European Respiratory Society (ERS) congress show that tiotropium significantly reduced asthma exacerbations in patients who remain symptomatic despite treatment with at least ICS/LABA.   

Tiotropium also significantly improved lung function in symptomatic asthma patients on ICS/LABA.   

These data are also being published simultaneously online in the New England Journal of Medicine available at http://www.nejm.org.

Professor Huib A M Kerstjens of the University Medical Centre, Groningen, The Netherlands, and lead author on both studies, said: "These results exceeded our expectations. While we were anticipating improvements in lung function when adding tiotropium to usual care, the significant reduction in the risk of exacerbations came as a surprise - especially given that all patients were already receiving optimal maintenance treatment as defined by the GINA guidelines."

The PrimoTinA-asthma^TM studies were two replicate double-blind parallel-group trials including asthma patients with post-bronchodilator FEV₁<80% predicted and asthma control questionnaire score ≥1.5 while on at least ICS/LABA. A total of 912 patients were randomised to additional tiotropium Respimat^® 5 μg or placebo for 48 weeks.

The pre-specified co-primary lung function endpoints included peak and trough FEV₁ at 24 weeks. Adding tiotropium Respimat^® provided significant lung function improvements at 24 weeks, which were sustained over 48 weeks.   

For the third co-primary endpoint, in the pre-specified combined analysis of the two trials, the addition of tiotropium Respimat^® was associated with a 21% risk reduction (HR 0.79, p=0.03) in time to first severe exacerbation. Severe exacerbations were defined as requiring systemic corticosteroids for atleast 3 days.

Furthermore, the addition of tiotropium Respimat^® reduced the risk of any asthma exacerbation, defined by a significant increase in symptoms or peak expiratory flow (PEF) drop ≥30% over ≥2 days, by 31% (P<0.0001).   

There were also significant improvements in asthma control and asthma related quality of life (evaluated by the questionnaires ACQ and AQLQ) in one trial, and a trend towards improvement in asthma control in the other study.   

Despite current treatment options, there still remains an unmet medical need in asthma, because a significant proportion of patients remain symptomatic and may experience asthma exacerbations.