Studies Show Once-Daily Alvesco(R) (ciclesonide) Has Minimal Mouth- and Throat-Related Side Effects in Asthma Patients
March 20 2004 - 2:00PM
PR Newswire (US)
Studies Show Once-Daily Alvesco(R) (ciclesonide) Has Minimal Mouth-
and Throat-Related Side Effects in Asthma Patients Latest Findings
of Investigational Inhaled Corticosteroid Presented at 2004 AAAAI
Annual Meeting SAN FRANCISCO, March 20 /PRNewswire-FirstCall/ --
New data show that once-daily treatment with the investigational
therapy Alvesco(R) (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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20000501/NYM197 ) 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 therapyfor 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 micrograms/day (CIC80), 160 micrograms/day
(CIC160), 320 micrograms/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 U.S. 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 euro 16.79 billion (US $18.99), invested euro
2.86 billion (US $3.24) in research and development and employed
approximately 69,000 people in its core business. Aventis corporate
headquarters are in Strasbourg, France. The company's prescription
drugs business is conducted in the U.S. by Aventis Pharmaceuticals
Inc., which is headquartered in Bridgewater, New Jersey. For more
information, please visit: http://www.aventis-us.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 regardingrisks 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 Reference"- on file with the
"Autorite des marches financiers" in France. To receive a copy of
this release or any recent release, visit the Aventis
Pharmaceuticals U.S. Web site at http://www.aventis-us.com/.
http://www.newscom.com/cgi-bin/prnh/20000501/NYM197DATASOURCE:
Aventis CONTACT: Corinne Hoff of Aventis Global Media Relations,
+33-3-88-99-19-16, , or Lise Geduldig, +1-215-416-9211, , or
Melissa Feltmann, +1-908-243-7080, , both of Aventis US Product
Communications Web site: http://www.aventis.com/
Copyright