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Ingelheim, Germany, May 22, 2012 – A Phase II study presented today at the 2012 Annual Meeting of the American Thoracic Society showed positive results for once-daily tiotropium via the Respimat® Soft Mist™ Inhaler (SMI) device in adolescents with symptomatic, moderate persistent asthma when added to usual care.1 Boehringer Ingelheim announced that the company has a comprehensive confirmatory phase III trial programme named UniTinA-asthma™ ongoing to fully evaluate the potential of the long-acting bronchodilator in the treatment of asthma.
The phase II 4-week, randomised, double-blind, placebo-controlled, incomplete cross-over dose-ranging study included 105 patients 12 to 17 years of age with moderate, persistent asthma on medium dose ICS with or without long-acting beta-agonist (LABA) or leukotriene receptor antagonists (LTRA). It demonstrated that all included dosages of once daily tiotropium (1.25 µg, 2.5 µg, 5 µg) increased lung function parameters tested (peak FEV1(0-3h), FEV1AUC(0-3h) and trough FEV1) compared to placebo. A statistically significant increase in lung function (peak FEV1(0-3h), FEV1AUC(0-3h) and trough FEV1) was observed with 5 µg tiotropium once daily which appears to be the preferred dose. Tiotropium was well tolerated in all dosages tested. These results are consistent with the previous Phase II proof of concept studies demonstrating positive clinical activity of tiotropium in adult patients with asthma.2,3
Dr Christian Vogelberg, of University Children's Hospital Dresden, Germany and Lead Author said: "Despite substantial advancements in the treatment of asthma and a wide range of available therapeutic options, a significant number of patients still remain symptomatic. These new results are encouraging because they show that treatment with tiotropium via the Respimat® SMI might positively impact lung function despite the fact that all study patients were already receiving usual care maintenance treatment as defined by the GINA guidelines."
Respimat® Soft Mist Inhaler (SMI) is a new generation inhaler that provides a unique, slow moving and long-lasting soft mist4,5 that is easy to inhale6 and produces superior lung deposition.7,8 Respimat® SMI is preferred by patients compared to other currently available inhalers.9,10,11
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, said: "These positive Phase II trial results in moderate asthma provide us with further confidence for our ambitious Phase III clinical trial program. We designed UniTinA-asthma™ to evaluate the full potential of tiotropium in this indication and will announce first results later this year. Ultimately, we hope to be able to develop a new treatment option for patients who remain symptomatic on usual care."
The comprehensive Phase III trial program UniTinA-asthma™ includes a number of clinical trials in adults, adolescents and paediatrics involving over 4000 patients in more than 150 sites globally.
Asthma is a chronic disease characterised by airway inflammation and bronchoconstriction.12,13 When a person with asthma comes into contact with an asthma trigger (e.g. infections, pollen, smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions cause the airways to become narrower and irritated, making it difficult to breathe.11 People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing.11
As of 2009, 300 million people worldwide were affected by asthma leading to approximately 250,000 deaths per year.11,14 Estimates have shown that the number of people with asthma could grow to as many as 400-450 million people worldwide by 2025.15
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.14 However, a significant number of patients suffer from uncontrolled asthma despite the available treatment options.15 They can continue to have symptoms and lifestyle restrictions and might even require emergency care.
Tiotropium (Spiriva®) is a long-acting inhaled anticholinergic medication 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 by targeting a dominant reversible mechanism - cholinergic bronchoconstriction and helping to keep them open for 24 hours. Boehringer Ingelheim has marketed tiotropium as Spiriva® since 2002 (10 years) in COPD.
About Respimat® Soft Mist™ Inhaler
Developed by Boehringer Ingelheim, Respimat® Soft Mist™ Inhaler (SMI) is a propellant-free, new generation inhaler with a unique delivery mechanism. It produces a long-lasting, slow moving Soft Mist™4,5 that is easy to inhale, easy to co-ordinate (forced inhalation is not required), reduces deposition in the mouth and throat and leads to superior lung deposition.6,7,8 Respimat® SMI is preferred by patients compared to other currently available inhalers.9,10,11
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 new 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).
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 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 endeavors.
In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
1 Vogelberg C, Leonaviciute-Klimantaviciene M, Vevere V, Vandewalker M, et al. Dose-ranging study of tiotropium as treatment for moderate persistent asthma in adolescents. ATS 2012 Abstract
2 Kerstjens H, Disse B, Schröder-Babo W, et al. Tiotropium improves lunch function in patients with severe uncontrolled asthma: A randomized controlled trial. J Allergy Clin Immunol 2011; 128(2): 308-314.
3 Bateman ED, Kornmann O, Schmidt P, et al. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 201;128(2):315-22.
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12 Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2010. http://www.ginasthma.org [Last Accessed November 2011].
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14 European Federation of Allergy and Airway Diseases Patients Association. 2011. http://www.efanet.org/asthma/index.html [Last Accessed November 2011]
15 Rabe KF et al. Worldwide severity and control of asthma in children and adults: the global asthma insights and reality surveys. J Allergy Clin Immunol. 2004 Jul;114(1):40-7.