New data show Striverdi® (olodaterol)* Respimat® improves exercise tolerance in patients with moderate to very severe COPD

• Data add to evidence from on-going Phase III clinical trial programme showing that once-daily olodaterol Respimat® provided fast, remarkable and sustained improvements in lung function in patients with moderate to very severe COPD^2,3,4,5

The latest data from Phase III studies show that treatment with once-daily olodaterol Respimat® resulted in statistically significant improvements in the amount of time that patients with chronic obstructive pulmonary disease (COPD) could exercise before breathlessness forced them to stop.

All patients involved in the studies had COPD with moderate to very severe lung function impairment, as defined by the GOLD guidelines.

What does this mean for the patient?

Reduced exercise tolerance is a common symptom of COPD and often worsens over time, limiting patients’ ability to do routine activities.^6,7

“Exercise is an essential component of COPD management – people living with COPD who exercise regularly have improved breathing, less severe symptoms and a better quality of life,” said Dr François Maltais, MD, of the Research Center, Québec University Institute of Cardiology and Pneumology, Laval University, Québec, Canada.

“These study findings are important because we see that the bronchodilator effect of olodaterol can also lead to meaningful improvements in the level of exercise that patients with COPD can undertake – a very important consideration in their holistic care,” Dr Maltais added.

Data from the two replicate 6-week studies showed that, compared to usual care, treatment with olodaterol Respimat® improved airflow limitation which translated into reduced lung hyperinflation during exercise producing improvements in symptom-limited exercise tolerance.¹ At Week 6, the exercise endurance time for patients receiving olodaterol Respimat® in Study 1222.37 was 14 percent greater than in the group of patients receiving usual care, and 12 percent greater than usual care in Study 1222.38.1

Usual care included short-acting anticholinergics (SAMAs), inhaled corticosteroids (ICS) and xanthines. Long-acting anticholinergics (LAMAs) were not permitted.

“These studies serve as another example of Boehringer Ingelheim’s commitment to advancing the treatment of COPD to address the unmet needs of millions of patients living with this devastating disease,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

These data are presented for the first time at the 2013 American College of Chest Physicians (ACCP) annual meeting (CHEST 2013) in Chicago.

Olodaterol Respimat® is both a fast-acting and long-lasting bronchodilator for the maintenance treatment of patients with COPD.

It has been shown in Phase III studies to deliver significant bronchodilator effects within 5 minutes after the first dose3 and provides sustained improvement in lung function over 24 hours that results in clinically meaningful improvements in patients’ quality of life.⁸

“We also look forward to results from our Phase III ANHELTO® studies evaluating the efficacy and safety of a free combination of tiotropium and olodaterol which are due to be reported in early 2014,” Professor Dugi continued.

References:

1. Maltais F. et al. Evaluation of the Effects of Olodaterol on Exercise Endurance in Patients with COPD: Results from Two 6-week Studies. CHEST 2013 Abstract no 748A.
2. Ferguson GT, Feldman GJ, Hofbauer P, et al. Lung function efficacy of olodaterol QD delivered via Respimat® in COPD patients: results from two 48-week studies. ERS 2013 oral presentation 186.
3. Koch A, Pizzichini E, Hamilton A, et al. Lung function efficacy of olodaterol QD delivered via Respimat® vs placebo and formoterol BID in patients with COPD: two 48-week studies. ERS 2013 poster no. P764.
4. Koch A, Paggiaro P, Hamilton A, et al. Symptomatic benefit of olodaterol QD delivered via Respimat® vs placebo and formoterol BID in patients with COPD: combined analysis from two 48-week studies. ERS 2013 poster no. P763.
5. McGarvey L, Koch A, Sachs P, et al. 48-week administration of olodaterol QD via Respimat® vs placebo and formoterol BID in patients with COPD: pooled safety analysis. ERS 2013 poster no. P3633.
6. Department of Health. Consultation on a Strategy for Services for Chronic Obstructive Pulmonary Disease (COPD) in England. February 2010. Accessible at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213840/dh_113279.pdf. Last accessed October 2013.
7. National Heart, Lung and Blood Institute. “What Is COPD?” July 2013. Accessible at http://www.nhlbi.nih.gov/health/health-topics/topics/copd/. Last accessed October 2013.
8. Lange P, Aumann J-L, Derom E, et al. The 24-h FEV1 time profile of olodaterol QD delivered via Respimat® in COPD: results from two 6-week studies. ERS 2013 oral presentation 4635.