SAN ANTONIO, Texas, March 22 /PRNewswire/ -- New data presented today at the American Academy of Allergy Asthma and Immunology 61st Annual Meeting show that once-daily treatment with the investigational therapy Alvesco(R) (ciclesonide) is associated with a low incidence of local oropharyngeal side effects (thrush, hoarseness and sore throat), and is well-tolerated in pediatric patients with mild-to-severe asthma.
"Inhaled corticosteroids are often associated with local mouth- and throat-related side effects that can negatively impact initiation of treatment and patient compliance, especially among children," states Erwin W. Gelfand, MD, Chairman of the Department of Pediatrics, National Jewish Medical and Research Center, Denver, and lead investigator of the study. "The low incidence of these side effects in our study demonstrates that Alvesco was well-tolerated in pediatric patients."
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
Ciclesonide tolerability and oropharyngeal adverse events were evaluated in two identical multicenter, multinational, double-blind, placebo-controlled, parallel-group clinical trials. A total of 1,031 pediatric patients with mild-to-severe persistent asthma were randomized to receive ciclesonide (CIC) 40 MCG (CIC40), 80 MCG (CIC80), 160 MCG (CIC160), or placebo once-daily for 12 weeks. At each study visit (weeks 1, 2, 4, 8 and 12), patients underwent oropharyngeal examination to test for oral candidiasis (thrush), and suspected oral fungal infections were verified by culture.
Within the safety population (n=1,025), only three cases (0.4%) of oral candidiasis were reported; all incidences occurred in the CIC groups (CIC80, n=1; CIC160, n=2). The incidence of pharyngitis (sore throat) was similar across all CIC groups, and only one case of hoarseness (0.1%) was reported in the CIC treatment group.
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.
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.
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 .
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
Poster Session #5200, 847