Value through Innovation27 November 2014
03 September 2012

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

  • First Phase III data for tiotropium delivered by the Respimat® SoftMistTM inhaler in asthma also demonstrate significant improvements in lung function in these patients1,2
  • Studies are part of Boehringer Ingelheim’s comprehensive ongoing Phase III UniTinA-asthmaTM programme
  • A significant proportion of asthma patients remain symptomatic despite current treatment options and may have asthma exacerbations3

Ingelheim, Germany, 3rd September, 2012 – 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

Professor Huib A.M. Kerstjens

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

Professor Klaus Dugi

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
§FEV1 Forced Expiratory Volume in one second

European Respiratory Society Annual Congress 2012 Boehringer Ingelheim tiotropium in asthma data

Abstract title: Tiotropium reduces asthma exacerbations in asthmatic patients with persistent airflow obstruction uncontrolled despite treatment in accordance with guidelines
Poster number: P1796
Session: C8, Session 214, 08:30-10:30, Monday, 03 September 2012
Abstract title: Tiotropium provides sustained bronchodilation in asthmatics with persistent airflow obstruction uncontrolled despite treatment in accordance with guidelines
Poster number: P2187
Session: Halle A-11, Session 249, 12:50-14:40, Monday, 03 September 2012

The Boehringer Ingelheim NewsHome: An innovative resource for journalists

www.NewsHome.com is THE site to discover more about Boehringer Ingelheim’s investigational compounds in respiratory and beyond. With a focus on Asthma, COPD and Idiopathic Pulmonary Fibrosis, the NewsHome contains Boehringer Ingelheim press releases, disease backgrounders, and other relevant materials like filmed expert opinion.

About Asthma
Asthma is a chronic disease characterised by airway inflammation and bronchoconstriction, leading to limited airflow into and out of the lungs and an increased production of mucus.4 When a person with asthma comes into contact with an asthma trigger (e.g. infections, pollen, smoke), their airways can become more inflamed, swollen and constricted and excess mucus is produced. These reactions cause the airways to become narrower and irritated, making it difficult to breathe.4 People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing.4

Estimates of the numbers of people affected by asthma worldwide vary from 100 to 300 million,5,6 with these numbers growing to as many as 400-450 million people worldwide by 2025.6

Worldwide, approximately 180,000 deaths are attributable to asthma each year,5 although there is considerable regional variation in mortality rates.7

By avoiding asthma triggers, one can help to reduce the severity of asthma. Although asthma cannot be cured, appropriate management can control the disease and enable people to enjoy a good quality of life. However, a significant number of patients suffer from uncontrolled asthma despite the available treatment options.3,8 They can continue to have symptoms and lifestyle restrictions and might even require emergency care.

About Tiotropium
Tiotropium is a long-acting inhaled anticholinergic bronchodilator and was the first inhaled maintenance treatment to provide significant and sustained improvements in lung function in COPD patients with once-daily dosing. Tiotropium works by opening narrowed airways and helping to keep them open for 24 hours.

About Respimat® Soft MistTM Inhaler
Developed by Boehringer Ingelheim, Respimat® Soft MistTM Inhaler (SMI) is a new generation inhaler delivering a unique Soft MistTM9,10 that is easy to inhale,11 and is preferred by patients compared to other currently available inhalers.12-15

Boehringer Ingelheim: Leading respiratory forward
Treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for over 90 years and significant resources are dedicated to research in this field. In addition to novel treatments for asthma, Boehringer Ingelheim has also branched out into developing treatment options for other airway diseases, including COPD, lung cancer, idiopathic pulmonary fibrosis and other respiratory indications. Boehringer Ingelheim’s respiratory portfolio covers a wide range of treatment options and includes Spiriva® (tiotropium), Berodual® (fenoterol/ipratropium), Berotec® (fenoterol), Combivent® (ipratropium/salbutamol) and Atrovent® (ipratropium).

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to be socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2011, Boehringer Ingelheim achieved net sales of about €13.2 billion. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

Pfizer Inc: Working together for a healthier worldTM
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global healthcare portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.

To learn more about our commitments, please visit us at www.pfizer.com

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].
6.  European Federation of Allergy and Airway Diseases Patients Association. http://www.efanet.org/asthma/index.html [Last Accessed 19/06/12].
7.  http://www.ginasthma.org/pdf/GINABurdenReport.pdf published in 2003 [Last Accessed 19/06/12].
8.  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): 40-7.
9.  Dhand R. Aerosol Plumes: Slow and Steady Wins The Race. J Aerosol Med 2005; 18(3): 261-63.
10. Hochrainer D, Hölz H. Comparison of Aerosol Velocity and Spray Duration of Respimat® Soft MistTM Inhaler and Pressurized Metered Dose Inhalers. J Aerosol Med 2005; 18(3): 273-282.
11. Freytag F, Golisch W, Wolf K. New soft mist inhaler is effective and easy to use in patients with asthma and COPD. Eur Respir J 2005;26(Suppl 49):338s.
12. Brand P et al. Respimat® Soft MistTM inhaler preferred to Diskus® by Patients with COPD and /or Asthma. J Aerosol Med 2007; 20(2): 165.
13. Hodder R, Price D. Patient Preference for Inhaler Devices in Chronic Obstructive Pulmonary Disease: Experience with Respimat® Soft MistTM Inhaler. Int J Chronic Obstruct Pulm Dis 2009; 4: 381-390.
14. Hodder R, Reese PR, Slaton T. Asthma Patients Prefer Respimat® Soft MistTM Inhaler to Turbohaler. Int J Chronic Obstruct Pulm Dis 2009; 4: 225-232.
15. Schuermann W, Schmidtmann S, Moroni P, et al. Respimat® Soft MistTM Inhaler versus hydrofluroalkane metered dose inhaler: patient preference and satisfaction. Treatm Respir Med 2005; 4: 53-61.

Media contact

  • Sebastian Wachtarz
    Boehringer Ingelheim

    Corporate Communications
    Sebastian Wachtarz
    Binger Strasse 173
    55216 Ingelheim am Rhein

    GERMANY

Media contact

  • Sebastian Wachtarz
    Boehringer Ingelheim

    Corporate Communications
    Sebastian Wachtarz
    Binger Strasse 173
    55216 Ingelheim am Rhein

    GERMANY

Prof. Huib A M Kerstjens

Professor Huib A M Kerstjens of the University Medical Centre, Groningen, The Netherlands

Using tiotropium in asthma

(WMV)

Prof. Klaus Dugi

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim

Boehringer Ingelheim’s UniTinA asthma programme

(WMV)