Press release
, 18.09.2007
Press Release - Health Canada Approves New Generation Asthma Medication For Adolescents

Oakville , ON September 18, 2007 – Canadian adolescents living with asthma now have a new treatment option which may help to address compliance with physician-recommended treatments.

Studies have shown that children with asthma become less compliant as they approach adolescence,[1] a time when they are often more concerned with their schoolwork and social life rather than their medication. Health Canada has extended the approval of Alvesco®, a novel, inhaled corticosteroid (ICS) treatment, to treat prophylactic management of steroid-responsive bronchial asthma in adults and adolescents 12 years of age and older. Alvesco® was previously approved in September 2006 for the prophylactic management of steroid-responsive bronchial asthma in adults 18 years of age and older. Alvesco® is marketed in Canada by Nycomed Canada Inc. (previously ALTANA Pharma Inc.)

Some of the common reasons for non-compliance among adolescents often include: denial of their disease; being too busy or distracted to remember to take their daily preventative treatment; the fear of being perceived as being different from their peers; and the awkwardness of taking medication at school or while out with friends. [2]

“One of the main challenges with treating asthma in adolescents is that they often don’t comply with their treatments,” said Dr. Harold Kim, an allergist and president of the Canadian Network of Asthma Care. “It's important for adolescents to maintain their asthma therapy, because untreated asthma can severely affect one's ability to lead an active life, as well an increase in hospitalization, and frequent absences from school.”

According to the Asthma Society of Canada, asthma is the leading cause of absenteeism from school and the third leading cause of work loss[3]. In addition, the prevalence of asthma among adults (15 years of age and older) has been increasing over the last 20 years.[4]

Health Canada Approves New Generation Asthma Medication for adolescents /2

How to help adolescents manage their asthma

Research suggests that there are several factors which can help adolescents remain compliant, and therefore gain more control over their asthma. Among them are working with a healthcare provider to develop an individual asthma action plan, providing adolescents with educational materials about their disease, such as pamphlets or videos, regular follow-up appointments with their physician, and taking a once or twice-daily inhaled preventative treatment, such as an ICS – the recommended first-line treatment for asthma according to the Canadian asthma guidelines.[5]

“Taking preventative inhaled medications can help prevent serious asthma attacks, and allow adolescents to lead full, fun and active lives.” says Dr. Kim. "The approval of Alvesco is a welcome treatment option for people with asthma in this age group because it provides a once-daily inhalation option for most patients. These unique qualities make it easier for those living with asthma to take their medication, and therefore could result in overall improved disease control."

Adolescents with asthma should also do their best to avoid potential triggers such as tobacco smoke, allergens (dust mites, molds, etc.) and sudden changes in weather temperatures.

Health Canada’s approval of Alvesco® for treatment of adolescents was based on results from double-blind, randomized, placebo-controlled studies 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 adolescent patients (aged 12 – 17 years), demonstrated comparable safety and efficacy between adult and adolescent patients.

In addition to Canada, Alvesco® is currently approved in 39 countries, including: the United Kingdom, Germany, Australia, Ireland, the Netherlands, Poland, Brazil, Chile, and Columbia.

About Alvesco® (ciclesonide)

Alvesco® is a new generation inhaled corticosteroid (ICS) indicated for the prophylactic management of steroid-responsive bronchial asthma in patients 12 years of age and older.[6] The recommended starting dose of Alvesco® therapy for most patients is 400μg, once daily.3 The recommended dose range is between 100μg and 800μg per day and can be administered as one or two puffs, once daily in either the morning or evening.3 Patients with more severe asthma may be more adequately controlled with Alvesco® 800μg daily, administered as 400μg twice daily.3

Health Canada Approves New Generation Asthma Medication for adolescents /3

Alvesco® allows for once-daily administration in most patients, providing effective therapy with a favourable safety and tolerability profile.[7],[8] Alvesco® is delivered to the lungs where it is activated and exerts its effect, and studies have shown that the activation of Alvesco® in the mouth and throat is minimal.

About Asthma in Canada

  • Canada has one of the highest incidences of asthma in the world[9] – affecting an estimated three million Canadians.[10]
  • The prevalence of asthma among adults (15 years of age and over) has been increasing over the last 20 years.[11]
  • Asthma is the leading cause of absenteeism from school and the third leading cause of work loss.[12]

About Nycomed Canada Inc.
Nycomed Canada Inc. is the Canadian subsidiary of Nycomed GmbH; a European based, privately owned research-based company. Through its innovative products and dedicated people, Nycomed is committed to improving the health of Canadians. In Canada, Nycomed is active in the therapeutic areas of gastroenterology, respirology and dermatology. Headquartered in Oakville, Ontario, the company employs more than 265 people across the country. Employees take pride in the corporate culture, and research and development is vital to the business. For more information, please visit www.nycomed.ca. Alvesco® is a registered trademark of Nycomed GmbH and is used under license.

For more information, please contact:

Jeanelle Frampton

Manning Selvage & Lee (MS&L)

T: 416-847-1306
E: jeanelle.frampton@mslpr.ca

References


[1] Dinwiddie R.1; Müller W.G. Adolescent treatment compliance in asthma. Journal of The Royal Society of Medicine, Volume 95, Number 2, 1 February 2002 , pp. 68-71(4).

[2] Ibid.

[3] Asthma Society of Canada, Asthma Facts & Statistics. Available at:

http://www.asthma.ca/corp/newsroom/pdf/asthmastats.pdf.

[4] Health Canada (1998b) The Burden of Asthma and Other Chronic Respiratory Diseases in Canada. Health Canada, Health Protection Branch, Respiratory Division – Facts and Figures, p. 87.

[5] Boulet L-P, Becker A, Bérubé D et al. for the Canadian Asthma Consensus Group. Canadian Asthma Consensus Report, 1999. CMAJ 1999;161 (11 Suppl).

[6] Alvesco Product Monograph, August 13, 2007.

[7] 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.

[8] 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.

[9] The Lung Association, retrieved November 2005 http://www.lung.ca/news/2005.04.28.asthma.media.guide.v3.pdf,pg.3.

[10] Asthma Society of Canada, November 2005; http://www.asthma.ca/adults/about/whoGetsAsthma.php.

[11] Health Canada (1998b) The Burden of Asthma and Other Chronic Respiratory Diseases in Canada. Health Canada, Health Protection Branch, Respiratory Division – Facts and Figures, p. 87.

[12] Asthma Society of Canada, Asthma Facts & Statistics. Available at:

http://www.asthma.ca/corp/newsroom/pdf/asthmastats.pdf.