INGELHEIM, Germany - Tuesday, March 8th 2016 [ME NewsWire]

    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 function5 and asthma symptom control and reduced asthma exacerbations for patients with allergic asthma1,2,3

(BUSINESS WIRE)-- 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.

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.6 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 actively7 delivers a unique mist,8 meaning the patient just needs to take a deep breath in9 for the medication to go deep into the lungs.10,11,12

“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.4,13

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.

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 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

6 electronic Medicines Compendium (eMC) http://www. medicines.org.uk/emc/medicine/2317/SPC/Seretide.

7 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

8 Zierenberg B. Optimising the in vitro performance of the Respimat®. J Aerosol Med 1999;12 (Suppl 1): S19-24.

9 SPIRIVA® Respimat® SPC 09/2014.

10 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.

11 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.

12 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.

13 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.

Contacts

Boehringer Ingelheim

Katharina Opitz

Phone: +49 6132 - 77 2012

Fax: +49 6132 - 77 6601

Email: press@boehringer-ingelheim.com

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