~ Health Canada approves new generation asthma medication to help children manage their disease ~
Oakville, ON - February 11, 2009 – Canadian parents of children with asthma may be lacking a sense of urgency and concern about the severity and management of their child’s disease, resulting in potential health risks to their children. According to the Paediatric Asthma In Canada survey, conducted by Leger Marketing, results show that although 74 per cent of parents describe their child’s asthma as mild, 17 per cent admit that their child still deals with an asthma attack at least once a month. In addition, parents of children with mild cases of asthma are less concerned than parents of children with moderate to severe asthma (58 per cent versus 92 per cent).
The Paediatric Asthma in Canada survey was developed based on findings from two focus groups and was sponsored by Nycomed Canada Inc. working with the Asthma Society of Canada (ASC). The survey was initiated to support Health Canada’s recent extension of Alvesco® (ciclesonide) to treat children six to 11 years of age. Alvesco® , an inhaled corticosteroid (ICS), is now approved for the prophylactic management of steroid-responsive bronchial asthma in children, adolescents and adults with varying disease severity.1 Alvesco® , marketed in Canada by Nycomed, is a novel and convenient, once-daily treatment option, which may help to address compliance with physician-recommended treatments.
The Paediatric Asthma in Canada survey goes on to show that in the past year, 44 per cent of parents have had to make unscheduled doctor appointments to deal with their child’s asthma, including more than 10 per cent making three or more unscheduled visits. In addition, 26 per cent of parents have had to take their child to the emergency department, including 14 per cent taking their child more than once.
"Our vision at the Asthma Society of Canada is to empower every child and adult in Canada with asthma to live an active and symptom-free life, so the results of this survey are alarming and unacceptable" says Christine Hampson, President and CEO of the Asthma Society of Canada. "All childhood asthma, regardless of the level of severity, should be a concern and be taken seriously – recurring asthma attacks, multiple unscheduled doctor appointments, and emergency room visits, are some of the signs that your child's asthma is not effectively controlled and may be undertreated. It could also mean that there is an issue with compliance, as some parents may not recognize the need for ongoing asthma treatment and do not administer medication as prescribed. Parents need to discuss their child’s asthma management with a professional," adds Hampson.
"My son has lived with moderate to severe asthma all his life and as a family we have always struggled to manage his asthma," said Lija Whittaker, a Canadian parent. "With busy schedules, it’s difficult to ensure that my son is controlling his asthma and following our doctor's recommendations. But as a parent, it’s important to be involved and become educated about your child’s asthma – especially about the daily use of their medications."
When it comes to the treatment of asthma, an overall 88 per cent of parents say their children use medication (95 per cent of moderate to severe cases versus 87 per cent of mild cases). Although the Canadian Asthma Guidelines recommend the once or twice-daily use of an inhaled preventative treatment, such as an ICS (which is the recommended first-line treatment for the daily management of asthma2 ), only 27 per cent of children use medication daily, whether they are experiencing problems or not – 46 per cent of children with moderate or severe asthma use their medication daily compared to only 18 per cent of children with mild asthma.
"A significant challenge of caring for children with asthma is that they often don’t comply with their treatments. This results in poor asthma control, frequent school absences, and trips to the doctor or emergency room," says Dr. Susan Waserman, Allergist/Clinical Immunologist, McMaster University, Hamilton, ON. The approval of Alvesco® is a welcome treatment option for children with asthma. It is a once-daily medication which is safe and well tolerated. This may make it easier for children to take their medication, leading to better compliance, and improved disease control."
The Survey also determined that parents are concerned with potential side effects of medication; most commonly noted are long-term side effects, including an impact on growth. "Limiting growth is a real worry for parents, especially with ICS therapy," says Dr. Denis Bérubé, pediatric pulmonologist, associate professor of pediatrics, CHU Sainte-Justine, Université de Montréal. "One of the key benefits of Alvesco® is that in clinical studies extending over a whole year, this ICS was shown to have no effect on growth rates compared to placebo when administered daily to children at doses of up to 200 micrograms per day. In shorter term studies, Alvesco® also showed a greater increase in height versus those treated with another commonly used ICS medication. This safety data should reassure parents and allow them to focus on the proper daily management of their child’s disease," adds Bérubé.
ASC Provides Updated Resource for Families
According to the Canadian Asthma Consensus Guidelines , asthma education is an essential component of asthma care.2 Although doctors are the primary source of information on asthma, management and treatments, the Paediatric Asthma in Canada survey confirmed the importance of the internet as a source of information. To provide information to the approximately two-thirds of parents who were not able to name a specific site for information, the ASC has updated and relaunched its two main websites for children ( http://www.asthmakids.ca/ ) and adolescents ( http://www.airsquare.ca/ ).
About Alvesco® (ciclesonide)
Alvesco® is a new generation ICS that allows for once-daily administration in most patients, providing effective therapy with a favourable safety and tolerability profile. 3,4 Alvesco® is delivered to the lungs where it is activated and exerts its effect; studies have shown that the activation of Alvesco® in the mouth and throat is minimal.1 The recommended dose range of Alvesco® therapy is between 100mcg and 800mcg per day for adults and adolescents 12 years of age and older and 100mcg to 200mcg per day for children six to 11 years of age. It can be administered as one or two puffs, once daily in either the morning or evening. 1 Patients with more severe asthma may be more adequately controlled with Alvesco® 800mcg daily, administered as 400mcg twice daily.
Health Canada’s approval of Alvesco® for the treatment of children was based on results from short- and long-term studies up to one year showing Alvesco® improves lung function, versus a placebo, which was measured by factors including improved asthma symptom control and reduced exacerbations. Overall, the studies, involving children (aged six to 11 years), demonstrated comparable safety and efficacy as seen in adult and adolescent patients. In addition, a between-treatment comparison showed a significantly greater increase in height in children treated with Alvesco® versus those treated with budesonide (p=0.0025).1
About the Paediatric Asthma in Canada Survey
The Paediatric Asthma in Canada survey was initiated to obtain insight into the knowledge of asthma among Canadian children with varying degrees of asthma severity and to identify unmet needs in treatment and management. Conducted by Leger Marketing, two separate national online surveys were implemented. The first survey polled 608 Canadian parents of children with asthma under the age of 13. A second survey was conducted among 215 Canadian physicians who treat children with asthma under the age of 13.
For the parent survey, the maximum margin of error of a sample of 608 is +/-4.0%, 19 times out of 20 of what they would have been had the entire Canadian Asthma patient population been polled. For the physician survey, the maximum margin of error of a sample size of 215 is +/6.7%, 19 times out of 20 of what they would have been had the entire Canadian physician population been polled.
About Nycomed Canada Inc.
Nycomed Canada Inc. is the Canadian subsidiary of Nycomed; a privately-owned, research-based pharmaceutical company. Nycomed is based in Oakville, Ontario, with more than 220 employees across the country. Through its innovative products and dedicated people, Nycomed is committed to improving the health of Canadians by providing brand name, science-based medicines that matter. For more information, please visit www.nycomed.ca. Alvesco® is a registered trademark of Nycomed GmbH and is used under license.
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For more information, please contact:
Lori Ann Horrigan
Corporate Affairs
Nycomed Canada Inc.
T: 905.465.4149
E: LoriAnn.Horrigan@nycomed.com
References
1 Alvesco® Product Monograph. January 23, 2009.
2 Becker A, Lemière C, Bérubé D et al. Summary of recommendation from the Canadian Asthma Consensus Guidelines, 2003 and Canadian Pediatric Asthma Consensus Guidelines, 2003 (updated to December 2004). CMAJ 2005; 173 (6 suppl): 51-556
3 Chapman KR, Boulet LP, D’Urzo AD, et al. Long-term administration of ciclesonide is safe and well tolerated in patients with persistent asthma. Presented at the 4th Triennial World Asthma Meeting. February 16-19, 2004; Bangkok, Thailand.
4 Derom E, Van De Velde V, Marissens S, Engelstaetter R, Vincken W, Pauwels R. Effects of inhaled ciclesonide and fluticasone propionate on cortisol secretion and airway responsiveness to adenosine 5’ monophosphate in asthmatic patients. Pulm Pharmacol Ther. 2005;18:328-336.