- 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 COPD2,3,4,5
CHICAGO, IL, USA I October 29, 2013 I 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.
Notes to editors
About the exercise tolerance studies
In the two 6-week, Phase III replicate, randomized, double-blind, placebo-controlled, three-way crossover studies, patients received olodaterol 5 μg or placebo via Respimat® once daily. Patients could continue receiving short-acting anticholinergics (SAMAs), inhaled corticosteroids (ICS) and xanthines as background therapy. Long-acting anticholinergics (LAMAs) were not permitted.About the olodaterol Respimat® Phase III clinical trial programme
The efficacy of olodaterol as a once-daily bronchodilator in patients with COPD is being evaluated by a robust clinical trial program involving more than 3,500 patients with COPD with moderate to very severe lung function impairment, as defined by the GOLD guidelines.About olodaterol Respimat®
Olodaterol Respimat® is a once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.Olodaterol Respimat® is approved for use in COPD in the UK, Canada Denmark, Iceland and Russia. Approval and regulatory reviews by health authorities in the US and other countries worldwide are pending.Boehringer Ingelheim is developing olodaterol Respimat® as a possible future combination partner for Spiriva® to provide additional bronchodilation in the maintenance treatment of patients with COPD. Combining a long-acting anticholinergic (LAMA) and a LABA has the potential to deliver increased bronchodilatory benefits in COPD symptoms and consistency of treatment response, compared to monotherapy.9Boehringer Ingelheim is 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.About Respimat® Soft Mist™ Inhaler
Developed by Boehringer Ingelheim, Respimat® Soft MistTM Inhaler (SMI) is a novel inhaler delivering a unique slow-moving Soft MistTM that allows pleasant inhalation – making it easy to inhale,10,11,12 and is preferred by patients compared to other currently available inhalers.13,14About COPD
COPD is a chronic lung syndrome, including chronic bronchitis and emphysema, dominated by progressive air flow limitation. Major symptoms are shortness of breath, chronic cough and sputum, and repeated exacerbations.15COPD is caused by long-term inhalation exposure to pollutants and noxious particles, most commonly cigarette smoke.15As COPD progresses, lung function declines and physical activity may become severely limited, disrupting the patient’s ability to lead a full life, interfering with everyday tasks and participation in family routines.15 This can lead to people feeling, anxious, isolated and depressed.16Bronchodilator medications are central to symptom management in COPD15 and inhaled bronchodilators are recommended in guidelines as first choice for the initial pharmacological management of COPD.15
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales. The treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for over 90 years and significant resources are dedicated to research in this therapy area.The Boehringer Ingelheim respiratory www.NewsHome.com is the one-stop-shop for clear, concise and easy to understand information about asthma and other respiratory illness for the media.
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.
[9] Cazzola M, Molimard M. The scientific rationale for combining long-acting β2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther 2010;23:257-267.
[10] Dhand R. Aerosol plumes: slow and steady wins the race. J Aerosol Med 2005;18(3):261-263.
[11] Hochrainer D, Hölz H, Kreher C, et al. Comparison of aerosol velocity and spray duration of Respimat® Soft MistTM inhaler and pressurized metered dose inhalers. J Aerosol Med 2005;18(3):273-282.
[12] Kardos P, Golisch W, Wolf K. New SoftMistTM Inhaler is effective and easy to use in patients with asthma and COPD. Eur Respir J 2005; 26 (Suppl 49): 338s.
[13] Hodder R, Reese PR, Slaton T. Asthma patients prefer Respimat® Soft MistTM Inhaler to Turbohaler®. Int J Chronic Obstruct Pulm Dis 2009;4:225-232.
[14] Schürmann W, Schmidtmann S, Moroni P, et al. Respimat® Soft MistTM inhaler versus hydrofluoroalkane metered dose inhaler: patient preference and satisfaction. Treatm Respir Med 2005;4:53-61.
[15] Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (updated 2013).
[16] Maurer J, Rebbapragada V, Borson S, et al. Anxiety and depression in COPD –current understanding, unanswered questions and research needs. Chest 2008;134;43S-56S.
SOURCE: Boehringer Ingelheim
