In this study, all doses of ciclesonide HFA (75mcg, 150mcg and 300mcg once-daily) met the primary efficacy endpoint and demonstrated a statistically significant reduction in 24-hour total nasal symptom scores (TNSS) versus placebo.
The study also met its secondary endpoint of instantaneous TNSS improvement versus placebo. There were no clinically meaningful differences in the incidences of adverse events (epistaxis, nasal discomfort and headache) between each of the ciclesonide HFA treatment groups and placebo.
Mark Corrigan, executive vice president, R&D at Sepracor, said: “We are encouraged by these study results and plan to initiate Phase III studies during the second half of 2008.”