Study Finds Alvesco® (ciclesonide) Did Not Affect HPA-Axis Function in Patients with Moderate-to-Severe Persistent Asthma
Bridgewater, NJ
September 14, 2005
Latest Data Published in the American College of Chest Physicians’ Journal

A new study demonstrates that moderate and high doses of the investigational therapy Alvesco® (ciclesonide), an inhaled corticosteroid, did not suppress hypothalamic-pituitary-adrenal-axis (HPA-axis) function in adults with moderate-to-severe persistent asthma as compared with placebo.  The data are published in the September 2005 issue of the journal CHEST. 

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 external stress.  While inhaled corticosteroids are generally accepted as first-line treatment for asthma, their potential for adverse systemic events can be assessed by the degree to which they cause HPA-axis suppression.

“Long term use of currently available inhaled corticosteroids at high doses is a concern because it has the potential to suppress the HPA-axis,” said Stanley Szefler, M.D. of the National Jewish Medical & Research Center, Denver, Colorado. “Our study, which is the first to examine treatment with high doses of ciclesonide for a prolonged duration in patients with asthma, demonstrated that HPA-axis function was not affected, even at the highest dose used.” 

Alvesco is an inhaled corticosteroid with novel release and distribution properties.  Inhaled corticosteroids, considered to be the foundation of asthma treatment, work by reducing inflammation – the underlying disease process – in the lungs and airways. 

Trial Design and Results
This was a single-center, randomized, double-blind, double-dummy, multiple-dose, parallel-group trial comparing the effects of ciclesonide (CIC), fluticasone propionate (FP), and placebo (PBO) on HPA-axis function in adult patients 18 years or older with moderate-to-severe asthma.  Sixty patients were randomized to receive 4 weeks treatment with CIC 320 µg bid (CIC 640), CIC 640 µg bid (CIC 1280), (FP) 440 µg bid (FP 880), FP 880 µg bid (FP 1760), or PBO.

After 29 days of treatment, CIC 640, CIC 1280 and FP 880 had no significant effect on mean serum cortisol AUC0-24h.  FP 1760 produced a statistically significant suppression in mean serum cortisol AUC0-24h as compared to PBO (P=0.0009, 95% CI -117.5; -32.1). Results obtained with cosyntropin stimulation revealed no statistically significant differences among the groups. The incidence of treatment-emergent adverse events was similar in all groups, and all adverse events were mild or moderate in severity.
About Alvesco
The sanofi-aventis Group and Altana Pharma 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 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.


About sanofi-aventis
The sanofi-aventis Group is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

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Sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc..


U.S. Contact
Melissa Feltmann, +1 908-243-7080,