Boehringer Ingelheim is currently developing a once-daily fixed-dose combination of its investigational LABA olodaterol and its well established LAMA tiotropium
The TOviTO® Phase III clinical trial programme is already underway to fully evaluate the potential of this combination
(BUSINESS WIRE)-- New phase II data presented for the first time today at the 2012 European Respiratory Society (ERS) congress show that combining tiotropium with olodaterol significantly improved lung function (FEV1B) over 24 hours in COPD patients compared to olodaterol alone.1
Significant improvements were seen for all combinations of doses tested (tiotropium 1.25, 2.5 and 5 μg / olodaterol 5 μg, 10 μg) compared with the respective olodaterol monotherapies.1 Both treatments were administered using the patient-preferred2-5 Respimat® Soft MistTM Inhaler (SMI) device.
After 4 weeks of treatment, the combination of tiotropium and olodaterol provided an average lung function improvement compared to the pre-treatment baseline of up to 342 mL over the first 6 hours (FEV1 AUC0-6) and improvements in trough FEV1C of up to 166 mL.
Compared to olodaterol monotherapy, the combination of tiotropium and olodaterol further increased lung function by up to 144 mL (FEV1 AUC0-6) and 84 mL (trough FEV1).
The new study completes a comprehensive Phase II programme initiated by Boehringer Ingelheim that thoroughly investigated different doses of each active component to identify the optimal doses for the fixed-dose combination.
Dr. René Aalbers of the Department of Pulmonology, Martini Hospital, Groningen, Netherlands, and lead author of the study said: “Combining two long-acting bronchodilators with different modes of action - the well established once-daily LAMAD tiotropium with olodaterol, an investigational and promising once-daily LABAE with a convincing 24-hour profile - has a complementary effect in the treatment of COPD patients. Olodaterol is an ideal partner to tiotropium due to its similar long-lasting effect at a low dose.”
The new data are from a Phase II dose-finding study: a randomised, double-blind, 4-period, incomplete crossover trial of 4 weeks duration involving 232 COPD patients with post-bronchodilator FEV1 of ≥30% and <80 br="br" normal.="normal." of="of" predicted="predicted">
To assist in the development of the fixed dose combination, various doses of tiotropium (1.25, 2.5 and 5 μg) were tested in combination with either olodaterol 5 μg or 10 μg and efficacy measured against the respective doses of olodaterol as monotherapy.
The study compared pre-dose (trough) lung function and lung function up to 6 hours post-dose after 4 weeks treatment with tiotropium and olodaterol as a free combination versus olodaterol as a monotherapy.
The mono components and all combination doses showed a favourable safety profile.
Comprehensive Phase III programme TOviTO® ongoing
The TOviTO® programme, one of the largest global Phase III clinical trial programmes ever conducted in COPD, is already underway to fully evaluate the potential benefits of tiotropium and olodaterol in a once-daily fixed-dose combination using Respimat® SMITM in the treatment of patients with COPD. It consists of several Phase III studies including the two pivotal registration trials TOnado 1&2, which are multi-centred, multi-national, randomised, double-blind, parallel group studies randomising a total of 5,000 COPD patients across the spectrum of disease severity from GOLD Stage II to GOLD Stage IV at more than 500 trial sites in approximately 40 countries.
In addition to evaluating the effects of tiotropium + olodaterol FDC on lung function, the TOviTO® programme is also focussed on the evaluation of other important clinical outcomes that reflect the daily life of patients with COPD.
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, said: “Olodaterol, a once-daily LABA with a proven 24-hour profile in patients with COPD, has been designed by Boehringer Ingelheim as an ideal combination partner for tiotropium, the first once-daily inhaled long-acting anticholinergic bronchodilator to provide 24-hour bronchodilation in COPD. These new data give us confidence that we are moving closer to the fixed dose combination product of tiotropium and olodaterol, which could become a new treatment option for patients with COPD.”
A The combination of tiotropium and olodaterol is not licensed for the treatment of COPD
B FEV1 is Forced Expiratory Volume in one second
C Trough FEV1 is Forced Expiratory Volume in one second at the end of the dosing interval (at approximately 24 hours post-treatment administration)
D Long-acting muscarinic antagonist
E Long-acting beta2-agonist
– Ends –
Please click on the link below for ‘Notes to Editors’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/03_september_2012_copd.html
References
Aalbers R, Maleki-Yazdi MR, Hamilton A, et al. Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat® inhaler in patients with COPD. ERS 2012 abstract P2882.
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.
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.
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.
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.
Confronting COPD in America: Executive Summary. New York, NY: Schulman, Ronca, and Bucuvalas Inc; 2001: 1-20.
From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/.
Maurer J , Rebbapragada B, Borsen S. et al. Anxiety and depression in COPD. Chest 2008; 134: 43S-56S.
http://www.who.int/respiratory/copd/burden/en/index.html [accessed 20/06/12].
http://www.who.int/respiratory/copd/en/ [accessed 20/06/12].
Yawn BP, Kaplan A. Co-morbidities in people with COPD: a result of multiple diseases, or multiple manifestations of smoking and reactive inflammation? Prim Care Respir J 2008;17 (4):199-205
Wilkinson TMA, Donaldson GC, Hurst JR et al. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 169: 1298-1303.
Dhand R. Aerosol Plumes: Slow and Steady Wins The Race. J Aerosol Med 2005; 18(3): 261-63.
Hochrainer D, Hölz H. Comparison of Aerosol Velocity and Spray Duration of Respimat® Soft MistTM Inhaler and Pressurized Metered Dose Inhalers. J Aerosol Med2005; 18(3): 273-282.
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.
Contacts
Boehringer Ingelheim
Corporate Communications
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Sebastian Wachtarz
Phone: +49 6132 – 77 3519
Email: press@boehringer-ingelheim.com
www.boehringer-ingelheim.com
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