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."
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%)
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.