Vol. 16 •Issue 21 • Page 18
New Asthma Drug Gets High Study Marks
Results of a randomized, double-blind, parallel-group, multi-center study spearheaded at University Hospital, Hamburg, Germany, and presented at the 13th annual Congress of the European Respiratory Society in Vienna, Austria, late last month showed that patients taking ciclesonide, a new inhaled corticosteroid (ICS) for the treatment of bronchial asthma, attained a significantly greater improvement in lung function than those taking budesonide, a current “gold standard” therapy.
On average, participants who received a once daily treatment of ciclesonide (320 µ) during the 12-week study period recorded significantly greater improvements in their forced expiratory volume and vital capacity, two common clinical parameters in pulmonary function testing, compared with budesonide (400 µ). Ciclesonide also showed an earlier onset of treatment benefits (at day 3) versus budesonide (at week 2).
“Ciclesonide is a unique inhaled corticosteroid that harvests all the desired qualities of currently marketed inhaled corticosteroids,” explained Dr. Dieter Ukena of University Hospital in Hamburg. Ciclesonide has high deposition at its activation site, the bronchi and the lungs. The unique property of ciclesonide is a phenomenon called “on site-activation”. Ciclesonide is metabolized into the active principle at the site where the asthmatic inflammation takes place. As a result, ciclesonide has a high rate of efficacy and less potential than other ICS for inducing local side effects. Whatever portion is absorbed into the bloodstream rapidly binds to proteins in the plasma and is inactive until it is cleared by the liver, so systemic side effects are likely lower than with other inhaled corticosteroids.
In another 12-week multi-center study, headed up by Dr. Trevor Hansel of the Imperial College in London, no statistically significant changes in urinary cortisol levels from baseline were recorded in asthma patients receiving ciclesonide (320 µ).
In contrast, there was statistically significant suppression of cortisol in budesonide (400 µ) treated patients. The observation that ciclesonide produced little cortisol suppression suggests a potentially important safety advance in ICS therapy. Cortisol is a hormone secreted by the adrenal cortex.
Research conducted at the Institut für Medizinforschung Allensbach, Germany, demonstrated that even after seven consecutive days of twice daily dosing, less ciclesonide than budesonide was circulating in serum. And an additional study demonstrated that serum levels of ciclesonide were similar after one single inhalation as after seven consecutive days of single inhalations.
According to Dr. Rüdiger Nave, of ALTANA Pharma AG, the lead researcher on the study, this extremely low systemic bioavailability may be one explanation for the absence of systemic adverse effects seen with ciclesonide.