BioCentury
ARTICLE | Clinical News

Omnaris HF ciclesonide: Preliminary Phase III data

July 5, 2010 7:00 AM UTC

Preliminary data from a Phase III trial in 671 patients ages 12 and up showed that 80 and 160 µg/day Omnaris HFA met the primary endpoint of significantly reducing reflective TNSS averaged over the 2-week treatment period vs. placebo (p<0.0001 for both). On secondary endpoints, both doses of Omnaris HFA significantly reduced instantaneous TNSS vs. placebo (p<0.0001 and p=0.0002, respectively), but only low-dose Omnaris HFA significantly improved ocular symptoms as measured by TOSS and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores vs. placebo (p=0.0124 for both). Omnaris HFA was well tolerated. ...