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Data Show Ciclesonide Has No Effect on HPA-Axis Function in Asthma Patients

ORLANDO, Fla., May 23 /PRNewswire-FirstCall/ -- New data show that once-daily treatment with the investigational therapy Alvesco® (ciclesonide) in mild-to-moderate asthma patients has no effect on adrenal function, as demonstrated by measurements of the hypothalamic-pituitary-adrenal (HPA)-axis. The data were presented at the 100th International Conference of the American Thoracic Society (ATS).

The HPA-axis is a major part of the neuroendocrine system, involving the interactions of the hypothalamus, the pituitary gland and the adrenal glands. The HPA-axis is believed to be a focus of the body's reactions to stress and is recognized as a surrogate marker for common adverse effects associated with the body's reaction to extra cortisol production as seen with steroid treatment. Inhaled corticosteroids are considered to be the foundation of asthma treatment. However, their use may be associated with HPA-axis suppression.

"Inhaled corticosteroids, while powerful, at times can predispose patients to potentially harmful side effects, such as slowed bone growth, osteoporosis, fluid retention, or other systemic side effects," said Edward M. Kerwin, MD, medical director, Clinical Research Institute of Southern Oregon and lead investigator of the study. "In this study, ciclesonide has shown no identifiable effects on the HPA-axis integrity. This indicates that the drug may have no detectable effects on the adrenal glands."

Trial Design and Results

Effects of ciclesonide (CIC) on the HPA-axis were investigated in two identical Phase III, multicenter, double-blind, randomized, placebo-controlled, parallel-group trials. Mild-to-moderate persistent asthma patients (n=1,015) ages twelve and older received CIC 80 mcg (CIC80), CIC 160 mcg (CIC160), CIC 320 mcg (CIC320) or placebo (PBO) once-daily in the morning for 12 weeks. HPA-axis function was assessed at baseline and at week 12 by determining peak serum cortisol levels stimulated by one mcg cosyntropin (n=179). Additionally, 24-hour urinary cortisol levels corrected for creatinine (n=176) were assessed.

Results of the two studies showed that no significant differences from baseline to week 12 in cosyntropin-stimulated peak serum cortisol levels or 24-hour urinary cortisol levels corrected for creatinine were observed for ciclesonide versus placebo. No statistically significant differences in the mean change from baseline in cosyntropin-stimulated peak cortisol (mcg/dL) after 12 weeks of treatment were observed for PBO, +0.49; CIC80, +0.22; CIC160, +1.51; and CIC320, +0.38 (P= NS for CIC80, CIC160, and CIC320 vs PBO).

No statistically significant differences in the mean change from baseline in 24-hour urinary cortisol levels corrected for creatinine (mcg/mg) after 12 weeks of treatment were observed for PBO, +0.0009; CIC80, -0.0013; CIC160, +0.0033; and CIC320, +0.0001 (P= NS for CIC80, CIC160, and CIC320 vs PBO).

About Alvesco

Alvesco is an inhaled corticosteroid with novel release and distribution properties. In December 2003, Aventis submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of Alvesco for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children four years of age and older. Aventis and Altana signed an agreement in 2001 to jointly develop and market Alvesco in the United States. The most frequently reported adverse events seen in Alvesco US clinical trials were nasopharyngitis, headache and upper respiratory tract infection.

About Asthma

Asthma is a chronic inflammatory disease of the lungs and airways. It is characterized by wheezing, coughing and a tightening of the airways, which causes shortness of breath and can be life-threatening. According to the Centers for Disease Control and Prevention (CDC), more than 20 million Americans report having asthma.

Source: Aventis

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