New Analyses: Adding SPIRIVA® Respimat® Effective for Uncontrolled Asthma – Regardless of Allergy Subtype1,2,3
- SPIRIVA® Respimat® shown effective in the broad range of asthma patients studied who continued to experience symptoms despite taking other asthma maintenance therapies4
- New analyses show improved lung function and asthma symptom control and reduced asthma exacerbations for patients with allergic asthma1,2,3
Ingelheim, Germany March 8, 2016 – Boehringer Ingelheim today announced the presentation of new post-hoc analyses that show the addition of SPIRIVA® (tiotropium) Respimat® to other asthma maintenance therapies helps improve lung function and asthma symptom control, while reducing asthma exacerbations (also known as flare-ups), independent of a patient’s subtype of allergic asthma.1,2,3 These data were presented at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles.
These analyses evaluated the safety and efficacy of adding SPIRIVA® Respimat® to other maintenance therapies compared to placebo across the broad range of asthma patients studied, regardless of the allergic (Immunoglobulin E or IgE) and inflammatory (eosinophilic) levels.
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The addition of SPIRIVA® Respimat® significantly improved lung function*.3 Adding SPIRIVA® Respimat® also was shown to improve asthma symptom control, as measured by the seven question Asthma Control Questionnaire (ACQ-7)2 and reduce the risk of asthma worsening and exacerbations.1
“The data confirm that adding SPIRIVA® Respimat® is a well-tolerated and effective treatment option for asthma patients independent of allergic subtype,” said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri. “For people with allergic asthma who are still experiencing symptoms, adding SPIRIVA® Respimat® may help open airways to improve breathing.”
People living with allergic asthma – the most common form of the condition – experience inflammation and a tightening of the airways due to exposure to common allergens. These patients may need other inhaled options that complement their existing therapy.
SPIRIVA® Respimat® is the first new class of inhaled medicine approved in over 10 years for asthma.5 It complements a patient’s other maintenance therapies (usually ICS/LABA) to reduce asthma symptoms and the risk of asthma flare-ups. SPIRIVA® Respimat® in asthma is delivered by Respimat®, the inhaler which actively† delivers a unique mist,6 meaning the patient just needs to take a deep breath in7 for the medication to go deep into the lungs.8,9,10
“Boehringer Ingelheim is committed to pursuing scientific research to help address unmet needs and improve patient care for people living with asthma,” said William Mezzanotte, Head of Respiratory Medicine, Boehringer Ingelheim. “These data further demonstrate the benefits of SPIRIVA® Respimat® for the broad range of asthma patients studied who continued to experience symptoms despite taking other maintenance therapies, regardless of allergy subtype.”
The post-hoc analyses are based on data from the two PrimoTinA-asthma® and two MezzoTinA-asthma® trials which are part of the UniTinA-asthma® large-scale clinical trial programme:
- The PrimoTinA-asthma® trials investigated SPIRIVA® Respimat® as an add-on therapy for adults with asthma who continued to have symptoms despite taking at least ICS/LABA therapy.
- The MezzoTinA-asthma® trials investigated SPIRIVA® Respimat® as an add-on therapy for adults with asthma who continued to have symptoms despite taking at least moderate-dose ICS therapy.
The safety and tolerability of SPIRIVA® Respimat® in each trial and treatment group were comparable with those of placebo in the overall patient population.4,11
For more information please visit www.boehringer-ingelheim-congress.com and www.respimat.com
About Asthma
Asthma is not solved. Almost 1 in 2 patients remain symptomatic despite their current maintenance therapies (usually ICS/LABA). These symptoms have a detrimental effect on their work, sleep, social life and intimate relationships. Additionally, symptoms increase their risk of potentially fatal asthma flare-ups in the next few weeks by up to six times.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.com
Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Referências
1 Casale, Thomas B. et al. Tiotropium Respimat® Add-on to at Least Ics Therapy Demonstrates Reduced Risk of Severe Asthma Exacerbation and Asthma Worsening in Symptomatic Asthma, Independent of IgE or Blood Eosinophil Levels. Journal of Allergy and Clinical Immunology , Volume 137 , Issue 2 , AB214.
2 Vandewalker, Mark L. et al. Once-Daily Tiotropium Respimat® Add-on to at Least Ics Maintenance Therapy Demonstrates Improved Asthma Control in Patients with Symptomatic Asthma, Independent of Serum IgE or Blood Eosinophil Levels. Journal of Allergy and Clinical Immunology , Volume 137 , Issue 2 , AB210.
3 Tashkin, Donald P. et al. Once-Daily Tiotropium Respimat® Add-on to at Least Ics Maintenance Therapy Demonstrates Improved Lung Function in Patients with Symptomatic Asthma, Independent of Serum IgE or Blood Eosinophil Levels. Journal of Allergy and Clinical Immunology , Volume 137 , Issue 2 , AB213.
4 Boehringer Ingelheim. Data on file.
5 electronic Medicines Compendium (eMC) http://www. medicines.org.uk/emc/medicine/2317/SPC/Seretide.
6 Zierenberg B. Optimising the in vitro performance of the Respimat®. J Aerosol Med 1999;12 (Suppl 1): S19-24.
7 SPIRIVA® Respimat® SPC 09/2014.
8 Newman SP, Brown J, Steed KP, et al. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: Comparison of Respimat® with conventional metered-dose inhalers with and without spacer devices. Chest 1998;113:957-63.
9 Pitcairn G, Reader S, Pavia D, Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med 2005;18(3):264-72.
10 Peterson JB, Prisk GK, Darquenne C. Aerosol deposition in the human lung periphery is increased by reduced-density gas breathing. J Aerosol Med Pulm Drug Deliv. 2008; 21(2):159–68.
11 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.
Footnotes
* as measured by peak forced expiratory volume (volume of air that can be forced out after taking a deep breath) in one second (FEV1) and trough FEV1
† Respimat® delivers a metered dose of medication in a mist at the push of a button not requiring the force from the patient’s inhalation