INGELHEIM, Germany--(BUSINESS WIRE)--For media outside the US, the UK & Canada only
Boehringer Ingelheim today announced that the indication for Spiriva® (tiotropium) Respimat®* in asthma has been accepted by the regulatory authorities in the EU. Spiriva® Respimat® is indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800µg budesonide/day or equivalent) and long-acting beta2-agonists and who experienced one or more severe exacerbations in the previous year.
The new indication for Spiriva® Respimat® in asthma is based on the UniTinA-asthma® large-scale, Phase III clinical trial programme which investigated adults with asthma who continued to have symptoms despite taking at least ICS‡ or ICS/LABA§ therapy.
New Phase III data from the UniTinA-asthma® programme presented today at The European Respiratory Society International Congress 2014 showed that Spiriva® Respimat® as an add-on treatment to ICS/LABA maintenance therapy:
- Significantly improved asthma symptoms7 - patients were 68% more likely to improve asthma control compared to usual care alone8
These new results add to existing evidence from the pivotal Phase III studies with patients on ICS/LABA therapy that demonstrated the addition of Spiriva® Respimat®:
Reduced the risk of patients having a severe asthma exacerbation by a
- reduced the number of patients who experienced a severe asthma exacerbation1
- Reduced the risk of patients’ asthma worsening by nearly a third (31%)1
The Phase III study results also showed that the safety of Spiriva® Respimat® is balanced as compared to placebo.1
Asthma is often seen as an easy to manage condition, and the misperception may exist that people with asthma symptoms can lead a normal life. However, patients who experience asthma symptoms have about a six times greater chance of having a potentially life-threatening asthma attack over the next few weeks than those with minimal-to-no daytime symptoms.5 Their physical, social and professional lives can also be affected significantly.9
“We know that, despite taking current treatment options, almost half of those with asthma still experience symptoms,2,3,4 which can put them at a significantly increased risk of an asthma attack.5 These statistics clearly highlight the critical need for new and effective asthma treatments such as Spiriva® Respimat®,” said Professor David Halpin, Consultant Physician & Honorary Associate Professor, Royal Devon & Exeter Hospital.
“Over the past decade, not much has changed in the range of therapies that we can offer patients so this new indication for Spiriva® Respimat® is an important and welcome advance in the treatment of asthma. Its unique mode of action in asthma provides physicians with a new option to help improve symptoms and reduce the number of patients who experience asthma exacerbations and worsenings that are not only frightening and very unpleasant, but can also be life-threatening,” Professor Halpin concluded.
Spiriva® Respimat® is an inhaled, long-acting, anticholinergic maintenance treatment. It works by opening airways and helping to keep them open for at least 24 hours.10,11,12 There are currently no other long-acting anticholinergic bronchodilators indicated for the treatment of asthma. Spiriva® Respimat® is already approved for the treatment of chronic obstructive lung disease (COPD), with comprehensive clinical trial data from more than 230 tiotropium COPD trials.13
“With more than 90 years of experience in the field of respiratory diseases, Boehringer Ingelheim is committed to bringing new treatment options to physicians and patients, particularly in areas of high unmet medical need. Asthma affects millions of patients across Europe,14 most people with asthma have low expectations of what can be achieved by asthma management and don’t realise that their condition can be improved,15” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.
"The regulatory acceptance of Spiriva® Respimat® in asthma establishes a new class of inhaled asthma therapy. Our extensive studies have demonstrated that Spiriva® Respimat® can help to improve outcomes for adult patients with asthma who remain symptomatic despite current standard treatments. In the clinical trials completed, Spiriva® Respimat® in asthma reduced healthcare utilisation, particularly in relation to the treatment of exacerbations,” Professor Dugi added.
For more detailed information please follow the links below:
- About Spiriva® Respimat® in asthma: http://bit.ly/1untlmF
- To view the 'notes to editors' and 'references': http://bit.ly/1vVD7PG
* Tiotropium Respimat® for use in asthma is currently being reviewed by regulatory authorities; it is approved as Spiriva® Respimat® for use in asthma in Chile, Colombia, Ecuador, Norway, Russia and Thailand and accepted in the EU. Spiriva® Respimat® is indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 µg budesonide/day or equivalent) and long-acting beta2-agonists and who experienced one or more severe exacerbations in the previous year
** defined as a deterioration of asthma symptoms that requires initiation or at least a doubling of systemic glucocorticoids for ≥3 days
† at least inhaled corticosteroid (ICS) plus long-acting beta2-agonist (LABA) therapy
‡ Inhaled corticosteroids
§ Long-acting beta2-agonists