Boehringer Ingelheim submits applications in Europe to extend the indication for the use of tiotropium Respimat® to the treatment of asthma in adults aged 18 years and over

• Data show that tiotropium Respimat® increased time to first severe exacerbation and first episode of asthma worsening in asthma patients who remain symptomatic despite at least ICS*/LABA† therapy¹
• Despite current treatment options, at least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations (attacks)²
• The applications are supported by pivotal data from UniTinA-asthma® Phase III clinical trial programme, which involves more than 4,000 patients in over 150 study sites globally, and is addressing the unmet medical need of patients who remain symptomatic despite today’s therapies
• Tiotropium is already approved for the treatment of COPD, with comprehensive clinical trial data from more than 190 tiotropium COPD trials³

Boehringer Ingelheim today announced submission of applications to extend the indication for the use of tiotropium (Spiriva®) Respimat® to the treatment of asthma in adults aged 18 years and over.

“Our extensive studies have demonstrated that tiotropium Respimat® has the potential to be an effective new treatment option which can provide benefits to, and improve outcomes for, adult patients with asthma.  Furthermore, we look forward to results from the paediatric UniTinA-asthma® Phase III studies which are anticipated to become available in 2014,⁴” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

“At least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations (attacks), despite using the available therapeutic options, and we believe that tiotropium, once approved, can help address this clear unmet medical need,” Professor Dugi continued.

The European Marketing Authorisation (MA) applications for tiotropium Respimat® are based on results from the UniTinA-asthma® Phase III clinical trial programme which involves more than 4,000 patients in over 150 sites globally.

The UniTinA-asthma® clinical trial programme was designed to evaluate the efficacy and safety of tiotropium Respimat® in patients with asthma. UniTinA-asthma® programme includes a total of 11 Phase III studies investigating tiotropium Respimat® added to standard treatment in adults, adolescents and children (age 1+) with persistent asthma across the spectrum of asthma severity.⁵

The first data to come from the UniTinA-asthma® Phase III clinical trial programme were the PrimoTinA-asthma® studies, which demonstrated the efficacy and safety of tiotropium in asthma patients who remained symptomatic despite treatment with at least ICS/LABA therapy.¹ Data from the PrimoTinA-asthma® studies, which have since been published in the New England Journal of Medicine, showed that the addition of tiotropium Respimat® significantly increased time to first severe asthma exacerbation, as well as time to first episode of asthma worsening compared with placebo (standard treatment).¹

Data from the MezzoTinA-asthma® Phase III twin studies, which were presented for the first time at the European Respiratory Society (ERS) Annual Congress (7-11 September 2013), were also included in the European MA applications for tiotropium Respimat® in asthma.^6,7 The MezzoTinA-asthma® Phase III twin studies showed that, in asthma patients who remain symptomatic despite moderate-dose maintenance ICS therapy, the addition of tiotropium Respimat® significantly improves lung function, provides sustained bronchodilation over 24 hours and provides a statistically significant and clinically relevant improvement in asthma control.^6,7

Tiotropium is already approved for the treatment of COPD, with comprehensive clinical trial data from more than 190 tiotropium COPD trials.³ In-market experience with tiotropium since its introduction via HandiHaler® 10 years ago includes more than 31 million patient-years of real life experience‡ to support its efficacy and safety profile.⁹

1. Kerstjens HAM, Engel M, Dahl R et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012; 367 (13): 1198-1207
2. Bateman ED, Boushey HA, Bousquet J, et al; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004;170 (8): 836-44
3. Boehringer Ingelheim. Data on file
4. Boehringer Ingelheim. Data on file
5. Boehringer Ingelheim. Data on file
6. Kerstjens HAM, Bleecker E, Meltzer E et al. Tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: lung function and safety ERS 2013 Abstract Number: 4629
7. Kerstjens HAM, Bleecker E, Meltzer E et al. Tiotropium as add-on to inhaled corticosteroids significantly improves asthma control as reflected by the ACQ responder rate ERS 2013 Abstract Number: P4130
8. Wise R, Anzueto A, Calverley P et al. TIOSPIR™: Large scale trial of tiotropium Respimat® vs. HandiHaler® (HH) in patients (pts) with COPD. ERS 2013 Abstract Number: P752
9. Boehringer Ingelheim. Data on file