New Data Demonstrate Alvesco® (ciclesonide) Significantly Improves Quality-of-Life for Patients with Mild-to-Moderate Asthma
San Antonio, TX
March 22, 2005
Latest Findings Presented at AAAAI 61st Annual Meeting

Researchers conclude that treatment taken once a day with the investigational therapy Alvesco® (ciclesonide) significantly improves quality-of-life compared with placebo in patients with mild-to-moderate asthma.  The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 61st Annual Meeting.  

“In addition to conventional indicators of lung function, quality-of-life assessments that provide data on an asthma patient’s daily physical, emotional and social difficulties are an important tool for evaluating response to treatment,” said Anjuli S. Nayak, MD, Assistant Professor in the Department of Pediatrics at the University of Illinois, College of Medicine, and lead investigator of this study. “Our findings, as seen in this study, demonstrate that Alvesco significantly improves the quality-of-life for patients 12 years and older with mild-to-moderate asthma.”

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 
The effect of ciclesonide on quality-of-life was evaluated in an integrated analysis of two identical phase III, 12-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group clinical trials.  A total of 1,015 patients with mild-to-moderate asthma (≥12 years; FEV1 60-85% predicted) were randomized to receive placebo or ciclesonide (CIC) 80 μg (CIC80), 160 μg (CIC160), or 320 μg (CIC320) once daily.  Quality-of-life was assessed using the overall score from the Juniper Asthma Quality-of-Life Questionnaire (AQLQ) and individual domain scores (activity limitation, symptoms, emotional function and exposure to environmental stimuli) were recorded at baseline and at weeks 4 and 12.  A minimally important difference (MID) of ≥0.5 was required for each domain or overall AQLQ score to reflect clinically important changes in quality-of-life. 

A significant improvement (P<0.0001) in the overall AQLQ score was observed for all CIC groups (CIC80, 0.36; CIC160, 0.47; CIC320, 0.55) versus placebo, from baseline to week 12. A similar trend was observed for all four individual domain scores, except the environmental stimuli domain in the CIC80 group. A change from baseline to week 12 in overall AQLQ score of ≥0.5 MID was noted in a greater proportion of patients in the CIC groups (CIC80, 47%; CIC160, 50%; and CIC320, 50.6%) versus placebo (31%).

About Alvesco
The sanofi-aventis Group 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 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

Sanofi-aventis is the world’s 3rd largest pharmaceutical company, ranking number 1 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 disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY)

The sanofi-aventis Group conducts business in the U.S. through its subsidiaries Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.

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U.S. Contact
Melissa Feltmann, +1 908-243-7080, melissa.feltmann@sanofi-aventis.com