Once-Daily Alvesco Has Minimal Mouth- and Throat-Related Side Effects in Asthma Patients

Main Category: Respiratory / Asthma
Article Date: 22 Mar 2004 - 0:00 PDT

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Latest Findings of Investigational Inhaled Corticosteroid Presented at 2004 AAAAI Annual Meeting

Aventis Press Release

Strasbourg, France - New data shows that once-daily treatment with the investigational therapy Alvesco® (ciclesonide) in mild-to-moderate asthma patients is well-tolerated, with an incidence of oropharyngeal side effects (thrush, hoarseness and sore throat) similar to placebo. The data were presented at the 2004 American Academy of Allergy, Asthma & Immunology (AAAAI) 60th Annual Meeting.

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.

"Inhaled corticosteroids are first-line therapy for all severities of persistent asthma, but patient tolerability and side effects like oral and throat infections can limit their use," said William E. Berger, MD, MBA, clinical professor, College of Medicine, Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine and lead investigator of the two studies.

"Ciclesonide is a promising new agent that when administered is activated when it enters the lungs. Our findings suggest that these release and distribution properties translate into less potential for local side effects."

Trial Design and Results

Investigators conducted two identical phase III, multicenter, double-blind, randomized, placebo-controlled, parallel-group trials. Mild-to-moderate asthma patients received either ciclesonide 80 μg/day (CIC80), 160 μg/day (CIC160), 320 μg/day (CIC320) or placebo once daily in the morning for 12 weeks. Tolerability and oropharyngeal side effects were monitored. Suspected oral fungal infections were verified by culture.

Results of the two studies showed that more patients on ciclesonide than those on placebo (85.2% vs. 66.7%) completed 12 weeks of treatment. Incidences of the following oropharyngeal side effects were similar for ciclesonide and placebo:

oral candidiasis or thrush (CIC80 1.2%, CIC160 0.0%, CIC320 1.6%, placebo 0.4%)
hoarseness (CIC80 0.4%, CIC160 0.0%, CIC320 0.8%, placebo 0.4%)
pharyngitis or sore throat (CIC80 5.4%, CIC160 4.0%, CIC320 5.1%, placebo 5.2%)

About Alvesco

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 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 Aventis

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of € 16.79 billion, invested € 2.86 billion in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.

Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -'Document de Référence'- on file with the "Autorité des marchés financiers" in France.

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