In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses equal to and greater than times the MRHDID in adults (on a mg/m 2 basis at maternal doses of mg/kg/day and higher) produced external and skeletal malformations and embryolethal effects (increased fetal resorptions). There were no effects in fetuses of pregnant rabbits administered a subcutaneous dose times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of mg/kg/day).
Asthma is a complex disease of the respiratory tract associated with chronic inflammation in which an intricate network of cells and cellular factors plays a major role. Asthma is one of the most common chronic diseases, with an estimated 300 million cases worldwide, imposing a considerable burden on society in morbidity, quality of life, and healthcare costs. Inhaled corticosteroids (ICSs) form the gold standard, first-line therapy in the effective management of persistent asthma and reduce morbidity and mortality from asthma. However, long-term use of high-dose ICS therapy has potential to cause systemic side effects—impaired growth in children, decreased bone mineral density, skin thinning and bruising, and cataracts. Hypothalamic–pituitary–adrenal-axis suppression, measured by serum or urine cortisol decrease, correlates with the occurrence of systemic side effects of high-dose ICSs. Therefore, cortisol may be a relevant surrogate marker to identify the potential for adverse effects from ICS therapy. Ciclesonide is a new generation ICS with demonstrable safety and efficacy in the treatment of asthma. The unique pharmacologic characteristics of ciclesonide, such as reduced local adverse effects, lack of cortisol suppression, and the option for once-daily dosing, may improve compliance with therapy and allow long-term use of ICSs without fear of systemic adverse effects.