FDAnews
www.fdanews.com/articles/72583-alvesco-reduces-oral-corticosteroid-use-in-patients-with-severe-asthma

Alvesco Reduces Oral Corticosteroid Use in Patients With Severe Asthma

May 23, 2005

New data show that treatment with the investigational therapy Alvesco, an inhaled corticosteroid, significantly reduced oral corticosteroid use in adults with severe, persistent asthma while maintaining asthma control.

The reduction of oral corticosteroid (OCS) use with the replacement of Alvesco (ciclesonide) was evaluated in a 141-patient, Phase III, 12-week, multinational trial. The minimal effective OCS dose was established for each patient during the baseline period. The primary objective was the percent reduction in OCS dose from baseline to Week 12. Secondary variables included the number of patients who eliminated OCS therapy and change in OCS dose.

The results showed that approximately 30 percent of patients treated with ciclesonide were able to eliminate their OCS use entirely. All ciclesonide doses resulted in a significant percentage change from baseline in OCS dose compared with placebo. Similarly, OCS dose was significantly changed from baseline in ciclesonide-treated patients.