SPIRIVA® RESPIMAT® Now Available in the U.S. for Maintenance Treatment of Asthma in Adults and Adolescents 

  • SPIRIVA® RESPIMAT® is the first new class of inhaled medicine approved in over 10 years for the treatment of asthma1
  • Despite current treatment options almost one in two patients with asthma still experience symptoms,2,3,4 increasing their risk of asthma exacerbations5

Ingelheim, Germany, February 4th, 2016 – Boehringer Ingelheim today announced that SPIRIVA® RESPIMAT® is now available for the treatment of asthma by prescription in U.S. pharmacies. The U.S. Food and Drug Administration (FDA) approved a once-daily dose of 2.5 µg for the long-term maintenance treatment of asthma in people ages 12 and older.6*  

“Despite taking other daily maintenance treatments, many people with asthma continue to experience symptoms, including coughing, wheezing, shortness of breath,” said Michael B. Foggs, MD, Chief of Allergy & Immunology, Advocate Medical Group, Advocate Health Care Chicago, IL.7,8 “For these patients, adding SPIRIVA® RESPIMAT® to maintenance controller therapy may help open airways to improve breathing and reduce the likelihood of an asthma flare-ups or exacerbations†.”6 

People with asthma who continue to experience symptoms during the course of a week have a six times greater chance of having an asthma flare-up in the following few weeks than those with minimal to no daytime symptoms.5 These persistent symptoms can have a negative impact on the ability to perform daily activities for people living with asthma. 

Unlike other asthma daily maintenance treatments, SPIRIVA® RESPIMAT® is from a new class of medications in asthma known as long-acting anticholinergics, the first new class of inhaled medicine approved in over 10 years for asthma.

SPIRIVA® RESPIMAT® in asthma is delivered by RESPIMAT®, the inhaler which actively‡ delivers a unique mist,9 meaning the patient just needs to breathe in naturally10 for the medication to go deep into the lungs.11,12,13 

“SPIRIVA® RESPIMAT® is a new treatment option for asthma patients who remain symptomatic despite their maintenance treatment,” said Dr. William Mezzanotte, Head of Respiratory Medicine, Boehringer Ingelheim. “SPIRIVA® RESPIMAT® significantly improves lung function and reduces the risk of exacerbations in patients who remain symptomatic despite their maintenance treatment and is included in the 2015 GINA Global Strategy for Asthma Management and Prevention.”

The FDA approved SPIRIVA® RESPIMAT® for the treatment of asthma based on efficacy and safety data from a comprehensive clinical trial program, including 12 trials of approximately 5,000 adults and adolescents with mild, moderate and severe symptomatic asthma on at least an inhaled corticosteroid (ICS).6 

For more information on the U.S. FDA approval of SPIRIVA® RESPIMAT® in asthma, see the respective U.S. press release here.

For more information on SPIRIVA® RESPIMAT® and asthma, please visit Boehringer Ingelheim News Centre. 
 

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.

Footnotes

* SPIRIVA® RESPIMAT® is not a treatment for sudden asthma symptoms
† An asthma exacerbation is defined as a progressive increase in asthma symptoms (shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms) or a decrease in a patient’s best morning peak expiratory flow (PEF) that requires treatment with systemic steroids for at least three days.
‡ RESPIMAT® delivers a metered dose of medication in a mist at the push of a button requiring just a slow deep breath from a patient

 

Referências

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3.     Partridge MR, Dal Negro RW, Olivieri D. Understanding patients with asthma and COPD: insights from a European study. Prim Care Respir J 2011; 20 (3): 315-323.
4.     Demoly P, Paggiaro P, Plaza V, et al. Prevalence of asthma control among adults in France, Germany, Italy, Spain and the UK. Eur Respir Rev 2009;18:(112):105–112.
5.     Bateman ED, Reddel HK, Eriksson G, et al. Overall asthma control: the relationship between current control and future risk. J Allergy Clin Immunol. 2010;125(3):600-8.
6.     Boehringer Ingelheim. Data on file.
7.     Peters SP, Jones CA, Haselkorn T, Mink DR, Valacer DJ, Weiss ST. Real-world Evaluation of Asthma Control and Treatment (REACT): findings from a national Web-based survey. J Allergy Clin Immunol. 2007;119(6):1454-1461.
8.     Reddel HK, Bateman ED, Allan Becker, et al. A summary of the new GINA strategy: a roadmap to asthma control. Eur Resp J 2015. Available at: http://erj.ersjournals. com/content/early/2015/07/23/13993003.00853-2015. abstract [accessed 20/01/2016].
9.     Zierenberg B. Optimising the in vitro performance of the RESPIMAT®. J Aerosol Med 1999;12 (Suppl 1): S19-24.
10.    SPIRIVA® RESPIMAT® SPC 09/2014.
11.    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.
12.    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.
13.    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.