Promising Phase II Data With Once-Daily Tiotropium may Lead to New Treatment Option for Adolescent Asthma Patients

BRACKNELL, England, May 23, 2012 /PRNewswire/ --

For UK medical, business and pharmaceutical media only

•   Data demonstrates clinical activity of tiotropium, a long-acting bronchodilator, in adolescents with asthma on top of usual care

•   Comprehensive Phase III UniTinA-asthma™ program ongoing

•   Once daily 5 mcg appears to be preferred dose

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.^[2]  

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 taking medium dose  inhaled corticosteroids (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 mcg, 2.5 mcg, 5 mcg) increased lung function parameters tested (peak FEV_1(0-3h), FEV_1AUC(0-3h) and trough FEV₁) compared to placebo. A statistically significant increase in lung function (peak FEV_1(0-3h), FEV_1AUC(0-3h) and trough FEV₁) was observed with 5 mcg tiotropium once daily, which appears to be the preferred dose.^[1]

Tiotropium was well tolerated in all dosages tested.^[1] These results are consistent with the previous Phase II proof of concept studies demonstrating positive clinical activity of tiotropium in adult patients with asthma.^[3;4]

Professor Ian Pavord, Consultant in Respiratory Medicine and Honorary Professor of Medicine at University Hospital of Leicester NHS Trust, said: "Despite substantial advances 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."

Dr Charles de Wet, Medical Director, 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 4,000 patients in more than 150 sites globally.^[2]

About asthma

Asthma is a chronic disorder of the airways, caused primarily by inflammatory processes and constriction of the smooth muscle in airway walls (bronchoconstriction). It is characterised by airflow obstruction and increased responsiveness of the airways to various stimuli (known as triggers). Symptoms include recurring episodes of wheezing, breathlessness, chest tightness and coughing. Typical asthma symptoms tend to be variable, intermittent and worse at night. Asthma is commonly triggered by viral respiratory infections, exercise, smoke, cold and allergens such as pollen, mould, animal fur and the house dust mite^[5]

It is estimated that there are 5.2 million people with asthma in the UK, of whom approximately 2.9 million are women and girls and 2.3 million are men and boys.^[5]

There is no cure for asthma, although people may experience long periods of remission. Poorly controlled asthma can have a significant impact on the quality of life of the affected person and their family. Clinical measures such as lung function may not correlate with an individual's quality of life scores, but if asthma is well controlled, near maximal scores on quality of life instruments can be achieved.^[5]

However, a significant number of patients suffer from uncontrolled asthma despite the available treatment options. They can continue to have symptoms and lifestyle restrictions and might even require emergency care.^[6]

About tiotropium

Tiotropium (Spiriva^®) is a long-acting muscarinic antagonist (LAMA) with a unique mode of action that works by opening narrowed airways by targeting a dominant reversible mechanism - cholinergic bronchoconstriction and helping to keep them open for 24 hours with once-daily dosing.^[7;8]

Tiotropium has comprehensive clinical trial data in treating chronic obstructive pulmonary disorder (COPD) symptoms demonstrating an extensive wealth of experience since its introduction almost 10 years ago and over 25 million patient years of real life experience to support the efficacy and safety profile^[9]

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 products of high therapeutic value for human and veterinary medicine.

A central element of Boehringer Ingelheim's culture is 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 endeavors.

In 2010, Boehringer Ingelheim posted net sales of about 13.2 billion euro while spending almost 23.5% of net sales in its largest business segment Prescription Medicines on research and development.

For more information please visit http://www.boehringer-ingelheim.co.uk

References

(1) Vogelberg C, Leonaviciute-Klimantaviciene M, Vevere V et al. Dose-ranging study of tiotropium as treatment for moderate persistent asthma in adolescents. Poster presented at ATS San Francisco. Am J Respir Crit Care Med 2012; 185(A4069).

(2) ClinicalTrials.gov. Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patients With Moderate to Severe Persistent Asthma. http://clinicaltrials.gov/ct2/show/NCT01340209 Last accessed: May 2012.

(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. Journal of Allergy and Clinical Immunology 2011; 128(2):315-322.

(4) Kerstjens HAM, Disse B, Schröder-Babo W et al. Tiotropium improves lung function in patients with severe uncontrolled asthma: A-randomized controlled trial. Journal of Allergy and Clinical Immunology 2011; 128(2):308-314.

(5) NHS National Institite for Health and Clinical Excellence. Inhaled corticosteroids for the treatment of chronic asthma in adults and in children aged 12 years and over. Health Technology Appraisal Guidance 138. March 2008.

(6) Rabe K, Adachi M, Lai C 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):40-47.

(7) Boehringer Ingelheim. Spiriva 18 microgram inhalation powder, hard capsule. Summary of Product Characteristics. (The Electronic Medicines Compendium) http://www.medicines.org.uk. Last accessed May 2012.

(8) Boehringer Ingelheim. Spiriva Respimat 2.5 micrograms solution for inhalation. Summary of Product Characteristics. (The Electronic Medicines Compendium) http://www.medicines.org.uk. Last accessed May 2012.

(9) Boehringer Ingelheim. Data on file.

For further information, please contact:
Esta Keywood
Communications Executive
Boehringer Ingelheim Limited
Tel: +44(0)1344-74-2534
esta.keywood@boehringer-ingelheim.com