Value through Innovation28 November 2014
27 August 2012

Key results from new tiotropium studies in COPD and asthma
to be presented at ERS 2012

  • First Phase III exacerbation and lung function data for tiotropium via the Respimat® inhaler in asthma*
  • New Phase II data on combination of tiotropium and olodaterol via Respimat® in COPD

Ingelheim, Germany, 27th August, 2012 – New data to be presented at the Annual Congress of the European Respiratory Society (ERS 2012), in Vienna, Austria, will shed light on the current and potential future role of tiotropium, the first once-daily long-acting inhaled anticholinergic for patients with Chronic Obstructive Pulmonary Disease (COPD).

Highlights from the accepted abstracts include the first Phase III exacerbation and lung function data for Boehringer Ingelheim’s and Pfizer’s tiotropium in asthma. These results derive from two replicate studies evaluating the efficacy of once-daily tiotropium administered by the Respimat® Soft MistTM Inhaler (SMI) in patients with severe asthma who remain symptomatic on at least ICS /LABA§ . The data are relevant since a significant proportion of patients with asthma remain symptomatic despite current treatment options and may have asthma exacerbations.1

A further presentation will focus on results from a Phase II study that investigates the potential of a future fixed-dose combination (FDC) of tiotropium and Boehringer Ingelheim’s once-daily LABA olodaterol in patients with COPD. This Phase II trial was looking at the impact of different doses of tiotropium and olodaterol as a free combination on lung function, both administered individually by the Respimat® SMI.

Boehringer Ingelheim has already started to evaluate the tiotropium and olodaterol FDC in the TOviTOTM Phase III clinical trial programme.

In addition, a new analysis of the four year UPLIFTTM data will be presented. This study evaluated the effect of tiotropium (18 µg via HandiHaler®) in low risk patients based on the newly defined patient groups in the updated report of the Global Initiative for Chronic Obstructive Lung Disease (GOLD). It will further add to the wealth of data for tiotropium in COPD, which has now been investigated in 175 clinical trials in COPD.

The ERS congress is the largest respiratory meeting in the World, with attendance from more than 100 countries.2 All tiotropium abstracts can be accessed through the ERS website, http://www.erscongress2012.org/.

*Tiotropium is not approved for the treatment of asthma
The combination of tiotropium and olodaterol is not approved for the treatment of COPD
Inhaled corticosteroids
§Long-acting ß-agonists

  Asthma

Topic Lead Author Presentation details
Exacerbation data from two Phase III studies evaluating efficacy of once-daily tiotropium in severe asthma patients symptomatic despite ICS/LABA therapy HAM Kerstjens Poster discussion
Monday 3rd September
08.30-10.30
Lung function data from two Phase III studies evaluating efficacy of once-daily tiotropium in severe asthma patients symptomatic despite ICS/LABA therapy HAM Kerstjens Poster session
Monday 3rd September
12.50-14.40

COPD

Topic Lead Author Presentation details
Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat® inhaler in patients with COPD R Aalbers Poster discussion
Monday 3rd September
14.45-16.45
Effectiveness of tiotropium in low-risk patients according to new GOLD severity grading D Halpin Poster session
Monday 3rd September
12.50-14.40

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 with once-daily dosing. Tiotropium works by opening narrowed airways and helping to keep them open for 24 hours.

About Tiotropium and Olodaterol in COPD
Olodaterol is a once-daily, long-acting beta2-agonist (LABA) that Boehringer Ingelheim has designed and developed as an ideal partner to tiotropium for patients with COPD. To date, olodaterol’s efficacy as a once-daily bronchodilator has been shown in clinical studies, with a significant increase in lung function for at least 24 hours in patients with COPD.

Boehringer Ingelheim is currently studying the efficacy of a once-daily fixed-dose combination of tiotropium and olodaterol in the TOviTO® Phase III clinical trial programme. The TOviTO® programme includes several trials that could provide important evidence to support this combination’s potential to become an important new treatment option for patients with COPD.

Boehringer Ingelheim: Leading respiratory forward
Treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for more than 90 years and significant resources are dedicated to research in this field. In addition to novel treatments for COPD, Boehringer Ingelheim is also developing treatment options for other airway diseases, including asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory indications. Boehringer Ingelheim’s respiratory portfolio and pipeline cover a wide range of treatment options.

About 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 in over 60 countries. 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 act 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.

For more information, please visit http://www.boehringer-ingelheim.com/ and follow us on Twitter at http://twitter.com/#!/Boehringer.

References

1. 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
2.http://www.erscongress2012.org/ (accessed 07/06/2012)

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