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| | Study Shows Once-Daily Alvesco® Does Not Affect Short-Term Leg Growth In Children With Asthma |
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date: Jul 22nd 2005 12:39
ALTANA Pharma announced today 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
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.
article 'Study Shows Once-Daily Alvesco® Does Not Affect Short-Term Leg Growth In Children With Asthma' source is Altana Pharma AG, visit source site:
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