The PrimoTinA-asthma studies (part of the ongoing phase III trial programme named UniTinA-asthma™) were two replicate double-blind parallel-group trials. Patients enrolled in the studies had a post-bronchodilator FEV1(1)<80% predicted and Asthma Control Questionnaire 7 (ACQ-7) score ≥1.5, while on at least high dose ICS/LABA. A total of 912 patients were randomised to additional once-daily tiotropium Respimat 5 mcg or placebo for 48 weeks.(2)
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 an increase in time to first severe asthma exacerbation (282 days vs. 226 days with placebo, as measured in the first quartile of patients.) This corresponds to a 21% relative risk reduction in numbers of patients with at least one severe exacerbation ([HR, 0.79; 95% CI 0.62 to 1.0; P=0.03] ARR 5.9% (26.9% vs. 32.8%))(2,3)
Further pre-specified secondary endpoints showed that the addition of tiotropium Respimat increased the time to first exacerbation of asthma (315 days, vs. 181 days with placebo) and a relative risk reduction of 31% of patients having any asthma exacerbation ([HR,0.69; 95% CI, 0.58 to 0.82; P<0.001] ARR 13.3% (49.9% vs. 63.2%))(2,3)
Dr Richard Russell, Consultant Chest Physician, Wexham Park Hospital and one of the UK study investigators said: “These results are promising for the many patients, who despite current treatment options, remain uncontrolled and prone to exacerbations.”
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.(1)
Dr Charles de Wet, Medical Director, Boehringer Ingelheim said: “We are excited by these results, which will likely be highly appreciated by both physicians and patients. The UniTinA-asthma 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.”
- Rabe KF, Adachi M, Lai CK et al. Worldwide severity and control of asthma in children and adults: the global Asthma Insights and Reality surveys. J Allergy Clin Immunol 2004; 114(1):40-47.
- Kerstjens HAM, Engel M, Dahl R. Tiotropium in Asthma Poorly Controlled with Standard Combination Therapy. N Engl J Med (online) 2012.
- Kerstjens HAM, Engel M, Dahl R. Tiotropium in Asthma Poorly Controlled with Standard Combination Therapy – Supplementary Appendix. N Engl J Med (online) 2012.