COMBIVENT® Respimat® and SPIRIVA® Respimat® Inhalers, the first in a new class of inhalers now approved in Canada, aim to address challenges
In a recent survey of COPD patients who use an inhaler, key issues include:1
BURLINGTON, ON, March 30, 2015 /CNW/ - Imagine you were unsure if your medication to help you breathe was working. This is the reality for Canadians living with Chronic Obstructive Pulmonary Disease (COPD), a progressive disease where the lungs become obstructed or blocked, making it hard to breathe.2 In fact, a recent survey of COPD patients who use an inhaler reveals that more than one-third (36 per cent) of people living with COPD are less motivated to use their inhaler as a result of the challenges they face.1
"The survey results are concerning because COPD medication helps to reduce exacerbations, or flare-ups, which are associated with a more rapid decline in breathing capacity," says Dr. Mark FitzGerald, Professor and Head, Respiratory Medicine, University of British Columbia. "Exacerbations are one of the biggest reasons for disability and hospitalization in COPD patients. So, it's very important that medication is taken as prescribed."
Canadians with COPD have a new inhalation treatment option, with the approval of two medications in the new Respimat® Soft Mist Inhaler. SPIRIVA® Respimat®, approved by Health Canada in December 2014 and COMBIVENT® Respimat®, approved in January 2014 are delivered through the Respimat® Inhaler.3,4 The Respimat® Inhaler is the first in a new class of inhalers known as a Soft Mist Inhaler, or SMI, that uses mechanical energy to deliver a soft mist. The slow-moving mist gives patients more time to inhale the dose of medication, and may improve delivery of medication to the lungs.5 The Respimat® Inhaler also has a dose indicator to help keep track of approximately how much medicine is remaining and locks after all doses have been delivered.3
"SPIRIVA® and COMBIVENT® have long been trusted therapies for COPD," says Dr. FitzGerald. "With these medicines in a new Soft Mist Inhaler, Canadians with COPD now have the option to start treatment on an inhaler that is easy-to-use and provides assurance that medication is being delivered. The challenges that we see from the survey could be alleviated with the availability of the new Respimat® Inhaler."
Chronic Obstructive Pulmonary Disease in Canada
COPD affects 1.5 million Canadians; however, an additional 1.6 million report having symptoms but have not been diagnosed.6 COPD advances through four stages, from mild to very severe.7 Flare-ups – also called exacerbations – are one of the most common reasons why people with COPD become disabled or have to be hospitalized.8 Flare-ups can be deadly, so it is important patients take their medication as prescribed.8
About De-mist-ifying COPD inhalers Survey
An online survey of 350 Canadians with COPD who currently use an inhaler as part of their treatment plan was completed online between December 18, 2014 and January 1, 2015 by Leger Marketing and funded by Boehringer Ingelheim (Canada) Ltd. A probability sample of the same size would yield a margin of error of +/- 5.2 per cent, 19 times out of 20.1
About SPIRIVA® Respimat®
SPIRIVA® Respimat® (tiotropium bromide monohydrate) is indicated as a long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, and for the reduction of exacerbations.3
The clinical trial database for COPD includes 3,282 SPIRIVA® Respimat® patients from seven placebo-controlled clinical trials with treatment periods ranging between four weeks and 48 weeks, contributing 2,440 person-years of exposure. Patients with severe unstable cardiac disease, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction were excluded from these studies.3
SPIRIVA® Respimat® was also evaluated inTIOtropium Safety and Performance In Respimat® (TIOSPIR™), a global landmark trial in more than 17,000 patients, one of the largest COPD trials ever conducted. Participants were recruited between May 2010 and April 2011 and were randomized to treatment in more than 1,200 investigator sites in 50 countries.9 The trial compared the safety and efficacy of SPIRIVA® Respimat® inhaler 2.5 μg (once a day, two puffs), or SPIRIVA® Respimat® 1.25 μg (once a day, two puffs) with SPIRIVA® HandiHaler® 18 µg. Over the three-year duration of the trial, TIOSPIR™ demonstrated that SPIRIVA® Respimat® 5 μg or 2.5 µg have similar exacerbation, safety and efficacy outcomes to the well-established profile of SPIRIVA® HandiHaler® 18 µg in COPD. In a spirometry substudy of TIOSPIR™, involving 1,370 participants, Respimat® 5 μg was non-inferior to HandiHaler for FEV1, but the Respimat® 2.5 μg dose was not.9
In controlled clinical studies, the most common adverse reactions (>3% incidence in the placebo-controlled trials with treatment durations between four and 48 weeks) were pharyngitis (11.5% vs. placebo 10.1%), cough (5.8% vs. placebo 5.5%), dry mouth (4.1% vs. placebo 1.6%), and sinusitis (3.1% vs. placebo 2.7%), which were usually mild.3
For more information regarding SPIRIVA® Respimat®, please consult the product monograph available here.
About COMBIVENT® Respimat®
COMBIVENT® Respimat® (ipratropium bromide and salbutamol sulfate) inhalation solution is indicated for treatment of bronchospasm associated with chronic obstructive pulmonary disease.4
Exposure for COMBIVENT® Respimat® is based on three well-controlled clinical trials in which a total of 3,043 COPD patients received at least one dose of trial medication.4
The most frequent side effects reported in a 12-week randomized, multicentre, double-blind, double-dummy, parallel-group trial comparing COMBIVENT® Respimat® (20/100 mcg), CFC-propelled COMBIVENT® Inhalation Aerosol (36/206 mcg), and ipratropium bromide delivered by the Respimat® Inhaler (20 mcg) administered four times a day in 1,460 adult COPD patients (955 males and 505 females) 40 years of age and older were as follows for COMBIVENT® Respimat®: headache (3%), throat irritation (<2%), cough (3%), dry mouth (<2%), gastro-intestinal motility disorders (<2%) (including constipation, diarrhoea and vomiting), nausea (<2%) and dizziness (<2%).4
For more information regarding COMBIVENT® Respimat®, please consult the product monograph available here.
About Boehringer Ingelheim (Canada) Ltd.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5 per cent of its net sales.
The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs more than 550 people across Canada.
References:
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1 Leger Marketing. Survey sponsored by Boehringer Ingelheim (Canada) Ltd. De-mist-ifying Inhalers. January 7, 2015.
2 The Lung Association. Chronic Obstructive Pulmonary Disease (COPD). http://www.lung.ca/copd. Accessed February 11, 2015.
3 SPIRIVA Respimat Product Monograph. February 6, 2015.
4 COMBIVENT Respimat Product Monograph. January 8, 2014.
5 Panos, Ralph J. Efficacy and safety of eco-friendly inhalers: focus on combination ipratropium bromide and albuterol in chronic obstructive pulmonary disease. Int J Chronic Obstruct Pulm Dis 8, 221 - 230 (2013).
6 Canadian Thoracic Society. Facts about COPD. http://www.respiratoryguidelines.ca/sites/all/files/COPD_fact_sheet.pdf. Accessed February 2, 2015.
7 Statistics Canada. Chronic obstructive pulmonary disease in Canadians, 2009 to 2011. http://www.statcan.gc.ca/pub/82-625-x/2012001/article/11709-eng.htm. Accessed February 4, 2015.
8 The Lung Association. Chronic Obstructive Pulmonary Disease (COPD) – Flare-ups. https://www.lung.ca/lung-health/lung-disease/copd/flare-ups. Accessed February 5, 2015.
9 Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, Dusser D, Joesph E, Kattenbeck S, Koenen-Bergnan M, Pledger G. Tiotropium Respimat Inhaler and Risk of Death. N Engl J Med 2013; 369:1491-1501.
SOURCE Boehringer Ingelheim (Canada) Ltd.
Image with caption: "New survey reveals Canadians with Chronic Obstructive Pulmonary Disease (COPD) lack confidence with their inhaler. (CNW Group/Boehringer Ingelheim (Canada) Ltd.)". Image available at: http://photos.newswire.ca/images/download/20150330_C6845_PHOTO_EN_13678.jpg
please visit www.boehringer-ingelheim.ca.
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