Phase III results: tiotropium* Respimat® significantly reduces exacerbations in asthma patients still symptomatic despite ICS/LABA treatment

Data from the PrimoTinA-asthmaTM 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‡ .1

Tiotropium also significantly improved lung function in symptomatic asthma patients on ICS/LABA.2

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-asthmaTM 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.2

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 at least 3 days.1

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).1

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.1,2

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.3

UniTinA-asthmaTM Phase III trial programme ongoing

The PrimoTinA-asthmaTM studies are part of Boehringer Ingelheim’s comprehensive ongoing Phase III trial programme named UniTinA-asthmaTM, which was designed to establish the efficacy and safety of tiotropium, delivered by the Respimat® SoftMistTM Inhaler (SMI) in patients with asthma. UniTinA-asthmaTM includes a number of clinical studies in adults, adolescents and and children (age 1+) with persistent asthma across the spectrum of asthma severity. These studies involve over 4000 patients in more than 150 sites globally.

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, said: “We are excited by these results, which will likely be highly appreciated by both physicians and patients. The UniTinA-asthmaTM trial programme is exploring whether tiotropium can address the clear unmet medical need seen in the significant number of asthma patients who remain symptomatic despite the available therapeutic options. This programme demonstrates our commitment to develop tiotropium Respimat® for a wide range of asthma patients. These first results give us confidence that tiotropium Respimat® has the potential to become an important new option in asthma treatment.”

*Tiotropium delivered by Respimat® is not licensed for the treatment of asthma

†Inhaled corticosteroids

‡Long-acting beta2-agonists

§FEV 1 Forced Expiratory Volume in one second

References

1. Kerstjens HAM, Engel M, Dahl R, et al. Tiotropium in Asthma Poorly Controlled with Standard Combination Therapy. N Eng J Med Published online 3 Sept 2012 (www.nejm.org).
2. Kerstjens HAM, Paggiaro PL, Vandewalker et al. Tiotropium provides sustained bronchodilation in asthmatics with persistent airflow obstruction uncontrolled despite treatment in accordance with guidelines. ERS 2012 abstract P2187.
3. Rabe, KF, Vermeire, PA, Soriano, JB, et al Clinical management of asthma in 1999: the Asthma Insights in Europe (AIRE) study. Eur Respir J 2000; 16, 802-807.
4. Global Initiative for Asthma (GINA). http://www.ginasthma.org/Questions-and-answers/q-a-general-information-about-asthma.html [Last Accessed 19/06/12].
5. World Health Organization. WHO factsheet 206: bronchial asthma. Available at: www.who.int/mediacentre/factsheets/fs206/en [Last Accessed 19/06/12].
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