Data Show Few Oropharyngeal Side Effects of Alvesco in Pediatric Asthma

Data presented at the American Academy of Allergy Asthma and Immunology 61st Annual Meeting show that once-daily treatment with the investigational therapy Alvesco 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.

Alvesco (ciclesonide) is an inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids, considered to be the foundation of asthma treatment, work by reducing inflammation in the lungs and airways.

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, 80 mcg, 160 mcg or placebo once daily for 12 weeks.

At each study visit (weeks one, two, four, eight 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, only three cases of oral candidiasis were reported; all incidences occurred in the CIC groups. The incidence of pharyngitis (sore throat) was similar across all CIC groups, and only one case of hoarseness was reported in the CIC treatment group.