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Phase III Results: Once daily olodaterol* Respimat® Provides Effective and Sustained Improvements in Lung Function in Patients with COPD1-3
|BARCELONA, Spain - Monday, September 9th 2013 [ME NewsWire]|
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Once-daily olodaterol Respimat® maintains lung function improvements in addition to usual care over 24 hours4 and has a rapid onset of action within 5 minutes after the first dose2
Lung function improvements with once-daily olodaterol Respimat® result in more COPD patients achieving clinically meaningful improvements in quality of life compared to usual care alone3
Data from two 48 week Phase III studies involving more than 3,000 patients show that olodaterol Respimat® in addition to usual care provides statistically significant improvements in lung function vs. usual care alone in patients with COPD (GOLD stages 2-4).1-3
Usual care background therapy included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthines.
Efficacy data from the trials demonstrate that once-daily olodaterol Respimat® has a rapid onset of action within 5 minutes after the first dose2 and maintains lung function over 24 hours.4
What does this mean for patients?
Compared to usual care alone, lung function improvements with once-daily olodaterol Respimat® resulted in a statistically significant, greater number of COPD patients achieving clinically meaningful improvements in their quality of life, as reflected by a decrease of more than 4 units in the St. George’s Respiratory Questionnaire (SGRQ)† total score.3
"Despite advances in the treatment of COPD, there remains a significant need to reduce the burden of COPD on patients’ lives. We are excited about these data because we see that the lung function improvements shown with olodaterol translate into patient related benefits over and above those seen with usual care, which reflects the need in a real-world situation,” said Dr Gary T Ferguson of the Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan, US.
"It is important to pay careful attention to permitted background therapies when interpreting the results of any bronchodilator study in COPD. A clinical trial where the active drug is compared against placebo in the absence of other background maintenance bronchodilator therapies is how COPD bronchodilator studies have been done. This methodology will more likely show a greater bronchodilator response vs. placebo than when other bronchodilator therapies are allowed in the placebo treatment group,” Dr. Ferguson concluded.
The addition of olodaterol Respimat® once-daily over 48 weeks provided statistically significant improvements in lung function vs. usual care alone (p<0.05) that were comparable to those shown with formoterol Aerolizer® 12 µg twice-daily.2
A responder analysis showed that more patients treated with olodaterol had a decrease in SGRQ total score greater than the minimal clinically important difference (MCID) of 4 units compared with usual care alone (P<0.001). For formoterol 12 μg, there was no significant difference compared with usual care alone in the number of patients with a decrease in SGRQ total score greater than the MCID (P=0.4621).
Safety data from the four 48-week Phase III parallel pivotal studies: two comparing olodaterol Respimat® vs. usual care alone and two comparing olodaterol Respimat® vs. formoterol Aerolizer® twice-daily, showed that, overall, the frequency of adverse events (AE) experienced with olodaterol was comparable to both placebo and the active comparator formoterol.5 The most common AE was COPD exacerbations.5
"We are committed to bringing olodaterol Respimat® to patients worldwide who need an additional treatment option. Boehringer Ingelheim has designed olodaterol Respimat® as a combination partner for tiotropium to provide additional bronchodilation in the maintenance treatment of COPD. We are currently undertaking a large global Phase III clinical trial programme in COPD - TOviTO® - to investigate the efficacy and safety of a combination of tiotropium with olodaterol in a once-daily fixed-dose combination using the Respimat® inhaler,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
"Olodaterol Respimat® has the potential to be an effective new treatment option for COPD patients and represents the next step in a series of important advances from our robust pipeline of respiratory treatments. This pipeline is driven by our passion for finding innovative ways to address the unmet needs of the millions of patients whose ability to lead a full life is disrupted by lung diseases. With these new treatment options, Boehringer Ingelheim continues to maintain leadership in COPD and to provide potential innovative solutions in other respiratory areas such as asthma, idiopathic pulmonary fibrosis (IPF) and lung cancer,” Professor Dugi concluded.
-- Ends --
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/09_september_2013olodaterol.html
* Olodaterol (Striverdi®) Respimat® is approved for use in COPD in Canada and Russia. Approval and regulatory reviews by health authorities in the US, Europe and other countries are pending.
† A 50-item questionnaire developed to measure health status (quality of life) in patients with COPD covering breathlessness in daily life and ability to exercise, as well as anxiety and depression. A decrease of 4 units in the SGRQ total score has been identified as the minimum clinically significant change
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