Ciclesonide HFA: Phase III data

A double-blind, U.S. Phase III trial in 1,111 patients aged 12 and older showed that once-daily 74 and 148 µg ciclesonide HFA for 6 months each met the primary endpoint of significantly improving reflective TNSS from baseline to week 6 vs. placebo (p<0.001 for both). On secondary endpoints, low- and high-dose ciclesonide HFA significantly improved instantaneous TNSS from baseline to week 6 vs. placebo (p<0.01 for both). Both doses of ciclesonide HFA also significantly improved overall RQLQ scores from baseline to week 6 in impaired patients with a baseline RQLQ score of >=3 points (p<0.01 for both). At 6 months, both doses of ciclesonide HFA significantly improved reflective TNSS (p<0.01 for both), instantaneous TNSS (p<0.05 for both) and overall RQLQ scores in impaired patients from baseline (p<0.01 for both). The most common adverse events were upper respiratory tract infection, epistaxis, headache, urinary tract infection, oropharyngeal pain, viral upper respiratory tract infection, instillation site discomfort, cough and nausea. Data were presented at the American College of Allergy, Asthma & Immunology meeting in Boston. ...