Ciclesonide does not Affect Short-term Leg Growth in Children
May 28, 2005 - 2:17:00 PM
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Because inhaled corticosteroids may be active outside the lungs, it is important to assess whether they are exerting systemic effects. However, since Alvesco is activated in the lung, oral exposure to active drug and risk for systemic side effects, such as reduced leg growth, appear to be limited.
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By Altana Pharma,
[RxPG] Altana Pharma announced that a study published in the May issue of the Journal of Allergy and Clinical Immunology demonstrated that once-daily Alvesco® (ciclesonide), a new inhaled corticosteroid for the treatment of asthma, does not affect short-term leg growth in children with mild asthma.
The study assessed the systemic effects of different doses of Alvesco® in children with mild asthma by measuring short-term linear lower-leg growth rate by knemometry, an extremely accurate measure of lower leg growth rate, and 12-hour overnight urine cortisol excretion. Short-term leg growth and cortisol excretion are two common indicators of systemic exposure to inhaled corticosteroids.
Alvesco has previously been shown to be clinically effective in both adults and children, however prior to this study few assessments of the systemic effects in children were available, noted lead investigator Soren Pederson, MD, Professor, at The University of Southern Denmark in Kolding. Because inhaled corticosteroids may be active outside the lungs, it is important to assess whether they are exerting systemic effects. However, since Alvesco is activated in the lung, oral exposure to active drug and risk for systemic side effects, such as reduced leg growth, appear to be limited.
In a double-blind, randomized, placebo-controlled, four-period cross-over study, 24 children, aged 6 to 12 years, received 40, 80 or 160 µg ciclesonide once-daily in the evening, or placebo. Each two-week treatment period was separated by a two-week washout period. Leg growth was measured using knemometry at the beginning and end of each treatment period. The two-week lower leg growth rate with once-daily ciclesonide therapy at 40, 80 and 160 ìg was 0.43 mm, 0.40 mm and 0.37 mm per week, respectively, while the two-week lower leg growth rate with placebo was 0.41 mm/week. The average change in leg growth seen with all doses of ciclesonide was statistically comparable to placebo.
Similarly, results of the 12-hour overnight urine cortisol excretion were not significantly different for ciclesonide and placebo, indicating minimal systemic exposure with ciclesonide. Mean urine cortisol excretion corrected for creatinine (nmol/mmol creatinine) with once-daily ciclesonide therapy at 40, 80 and 160 ìg was 8.5, 7.0 and 9.0, respectively, and 7.9 for placebo.
Publication:
The study is published in the May issue of the Journal of Allergy and Clinical Immunology
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Additional information about the news article
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Further Information About Alvesco®
Alvesco® is currently approved in more than 20 countries and to-date has been launched in the UK and Germany. UK served as the Reference Member State for the Mutual Recognition Procedure of Alvesco® in other European countries and 20 European countries have mutually agreed to the summary of product characteristics (SmPC) for Alvesco®. ALTANA Pharma plans further Alvesco® launches worldwide later this year. A New Drug Application (NDA) for Alvesco® has been filed with the U.S. FDA.
Alvesco® is an inhaled corticosteroid with novel release and distribution properties resulting in lung-targeted anti-inflammatory effects. Inhaled corticosteroids (ICS) are considered to be the foundation of asthma treatment, work by reducing inflammation - the underlying disease process - in the lungs and airways.
Ciclesonide: A Broader Product Platform
In addition to Alvesco®, a newly launched orally inhaled corticosteroid, the platform also includes ciclesonide nasal spray (phase III) and ciclesonide as a fixed combination product with formoterol (phase II). ALTANA partners with Sanofi-Aventis in the United States and with Teijin in Japan on the future marketing and distribution of ciclesonide.
About Asthma
Asthma is a chronic lung disease caused by airway inflammation and results in airway constriction in response to certain stimuli. It is characterized by a variety of symptoms including wheezing, coughing and a tightening of the airways, which causes shortness of breath and can be life-threatening. The prevalence of asthma is increasing by approximately 50 percent every decade and worldwide deaths from asthma total more than 180,000 annually.
This press release contains forward-looking statements, i.e., current estimates or expectations of future events or future results. The forward-looking statements appearing in this press release include ALTANA's plans to launch Alvesco® in further countries in 2005. These statements are based on beliefs of ALTANA's management as well as assumptions made by and information currently available to ALTANA. Many factors that ALTANA is unable to predict with accuracy could cause ALTANA's actual results, performance or achievements to be materially different from those that may be expressed or implied by such forward-looking statements. These factors include ALTANA's ability to develop and launch new and innovative pharmaceutical products, the granting of marketing approvals by the competent authorities, price regulations for pharmaceuticals and budgeting decisions of local governments and health care providers, the level of ALTANA's investment in pharmaceuticals related R&D, the sales and marketing methods used by ALTANA to distribute its pharmaceuticals. Forward-looking statements speak only as of the date they are made. ALTANA does not intend, and does not assume any obligation, to update forward-looking statements to reflect facts, circumstances or events that have occurred or changed after such statements have been made.
For inquiries:
ALTANA Pharma AG
Corporate Communications
Dr. Josef Goetz
Phone: +49. 7531.84-2284
Fax: +49.7531.84-92284
e-mail: [email protected]
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