AAAAI 2014 ASTHMA: New Phase III data show tiotropium* Respimat® effective across asthma severities

For Media outside the U.S., Canada and UK

  • Significant unmet medical need in patients with asthma who continue to experience symptoms despite current standard treatments
  • Improved understanding of tiotropium Respimat ®  as add-on treatment for patients with different severities of asthma
  • Results add to existing evidence of efficacy and safety of tiotropium Respimat ® in patients who remained symptomatic despite treatment with at least ICS† /LABA‡

San Diego, CA, March 1, 2014 – Boehringer Ingelheim today announced new data from large scale, Phase III studies showing that once-daily tiotropium delivered via the Respimat® inhaler was effective and well tolerated in patients across asthma severities.  These data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2014 annual meeting in San Diego.

“Even with current treatment options, at least 40 percent of patients with asthma remain symptomatic,1which may put them at greater risk for exacerbations or asthma worsening" said Professor Pierluigi Paggiaro, Professor of Respiratory Medicine, University of Pisa, and lead author on the GraziaTinA-asthma® study. “It is important to investigate the efficacy and safety of new treatment options across different asthma severities.”

The first results from the Phase III GraziaTinA-asthma® study were announced. The study demonstrated that tiotropium Respimat® improved lung function and was well tolerated in patients with asthma who remain symptomatic while receiving low-dose maintenance ICS treatment.2

Also presented at the meeting was a new subset of data from the Phase III MezzoTinA-asthma® trials. The data showed that in patients with asthma who remained symptomatic while receiving moderate-dose maintenance ICS therapy, the addition of once-daily tiotropium reduced airflow obstruction independent of allergic status, as measured by the TH2 phenotype biomarker.3

Finally, an analysis of a subset from the Phase III PrimoTinA-asthma® trials found the addition of once-daily tiotropium improved lung function responses independently of concomitant use of a leukotriene receptor antagonist (LTRA). This effect was demonstrated in patients with asthma who remained symptomatic despite receiving treatment with at least ICS/LABA.4 Previous results from these pivotal, PrimoTinA-asthma® trials have shown 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 at least ICS/LABA therapy alone (current standard therapy).5

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 140 affiliates and more than 46,000 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.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales. The 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 therapy area.

The Boehringer Ingelheim respiratory www.NewsHome.com is the one-stop-shop for clear, concise and easy to understand information about asthma and other respiratory illness for the media.

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Footnotes

*Please note: Tiotropium Respimat® is currently NOT APPROVED for use in asthma, except in Colombia. Tiotropium’s safety and efficacy have not yet been fully established in asthma
†inhaled corticosteroid
‡Long-acting beta2-agonists

Referências

  1. 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
  2.  Paggiaro P, Halpin DMG, Buhl R et al. Tiotropium Respimat® add-on to inhaled corticosteroids improves lung function in patients with symptomatic mild asthma: results from a Phase III trial. Journal of Allergy and Clinical Immunology Vol. 133, Issue 2: AB4
  3.  Casale T B, Bateman E D, Dahl R et al. Tiotropium Respimat® add-on therapy reduces airflow obstruction in patients with symptomatic moderate asthma, independent of TH2 inflammatory status. Journal of Allergy and Clinical Immunology Vol. 133, Issue 2: AB5
  4.  Dahl R, Doherty D E, Corren J. Once-daily tiotropium Respimat® improves lung function in patients with severe symptomatic asthma independent of leukotriene modifier use. Journal of Allergy and Clinical Immunology Vol. 133, Issue 2: AB5
  5.  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