INGELHEIM, Germany. - Monday, September 1st 2014 [ME NewsWire]
First presentation of positive results from pivotal, Phase III TONADO™ studies that supported recent regulatory submissions in Europe and US for tiotropium + olodaterol Respimat®*in COPD - the only fixed-dose combination (FDC) containing tiotropium
Data further confirming role of Spiriva® in delivering long-term benefits to COPD patients and in helping to establish COPD management strategy
Pooled Phase III data from large UniTinA-asthma® clinical trial programme showing improvement in both symptom control and risk of exacerbations across asthma severities by adding tiotropium Respimat®† to at least maintenance inhaled corticosteroid (ICS) therapy
Further analyses of the INPULSIS™ Phase III trials confirming the robustness of the primary and key secondary endpoint results for nintedanib‡ in IPF. An additional pre-specified subgroup analysis showing similar effects of nintedanib‡ in slowing disease progression, independent of severity of lung function impairment at baseline will also be presented
A total of 18 abstracts with key data across COPD, asthma and IPF will be presented
(BUSINESS WIRE)-- For media outside UK, US and Canada
The European Respiratory Society (ERS) International Congress, in Munich, Germany, September 6-10, 2014 sets the scene for important announcements across the substantial Boehringer Ingelheim respiratory portfolio. Data to be presented cover new advances in chronic obstructive pulmonary disease (COPD) treatment approaches, further supporting data for tiotropium Respimat® in asthma and rare disease insights for idiopathic pulmonary fibrosis (IPF).
With a total of 18 abstracts presented during ERS 2014, the data will highlight the importance of the company’s focus on respiratory research and advances in addressing unmet needs for patients living with certain lung diseases. Further detailed presentations and information will be provided in two media briefings during the congress.
COPD: Tiotropium + olodaterol Respimat® FDC and Spiriva® (tiotropium)
For the first time, data from the pivotal, 52-week TONADO™ Phase III studies§ involving more than 5,000 patients with COPD will be presented. The TONADO™ studies compared clinical outcomes in patients receiving tiotropium + olodaterol FDC delivered via the Respimat® Soft Mist™ Inhaler with those on tiotropium or olodaterol (Striverdi®) alone. The data from the TONADO™ studies formed a major part of Boehringer Ingelheim’s recent regulatory submissions in Europe and the US for tiotropium + olodaterol Respimat® FDC in COPD.
These important advances are underpinned by in-depth analyses of Spiriva® clinical trials that demonstrate an extensive wealth of experience since its introduction over 10 years ago** and over 40 million patient-years of real life experience supporting its safety and efficacy.1-7
Further analysis of one of the largest COPD trials, TIOSPIR™, highlights the predictors of debilitating COPD exacerbations and reinforces the need to treat COPD patients early. Spiriva®has shown a positive impact on reducing the risk of these lung attacks across a broad range of severities of COPD patients.††,3,6,8
Tiotropium Respimat® in asthma
Further highlights from the accepted ERS abstracts include studies looking at the impact of adding tiotropium Respimat® to at least ICS maintenance therapy on improving symptom control and reducing the risk of exacerbations across asthma severities. Using results pooled from the large UniTinA-asthma® international Phase III clinical trial programme including the PrimoTinA-asthma®, MezzoTinA-asthma® and GraziaTinA-asthma® trials, these new data will add to existing evidence that has shown the efficacy and safety of tiotropium Respimat® in patients with asthma who continue to experience symptoms despite treatment with at least ICS with or without LABA therapy. Despite current treatment options, almost one in two patients with asthma still have asthma symptoms9,10,11 and may experience frightening and life-threatening asthma exacerbations.
Idiopathic Pulmonary Fibrosis (IPF)
Abstracts to be presented at ERS show further data from the two Phase III INPULSIS™ trials, investigating nintedanib‡ 150 mg twice daily in the treatment of IPF.12 The primary endpoint was the annual rate of decline in forced vital capacity (FVC).12 Key secondary endpoints were: change from baseline in health-related quality of life, as assessed by the Saint-George’s Respiratory Questionnaire (SGRQ) and time to first acute exacerbation.12 The robustness of the primary and key secondary endpoint results is supported by sensitivity analyses.13
A pre-specified subgroup analysis of pooled data from the INPULSIS™ trials showed that nintedanib‡ 150 mg twice daily slowed the decline in lung function in patients with IPF, independent of severity of lung function impairment at baseline.14 In addition, nintedanib‡ reduced the proportion of patients with IPF who experienced disease progression as measured by categorical FVC decline.15
For ‘Notes to Editors’ along with a list of abstracts and sessions visit: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/01_september_2014_Respiratory.html
* The fixed-dose combination of tiotropium + olodaterol is an investigational treatment. Its safety and efficacy have not yet been fully established.
† 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, Russia, and Thailand.
‡ Nintedanib is an investigational compound. Its safety and efficacy has not yet been fully established.
§ TONADO™ consists of two replicate Phase III studies called TONADO™ 1&2
** 18 µg delivered via HandiHaler®
†† While Spiriva® 18 µg via HandiHaler® did not alter the rate of decline in lung function, a coprimary endpoint in the UPLIFT® study, it sustained greater improvements in lung function vs. placebo
Media + PR
Dr Kristin Jakobs
Phone: +49 (6132) 77-144553
Fax: +49 (6132) 77-6601