Patients received either placebo or PreHistin during a six week trial; three weeks were administered prior to the onset of the allergy season, and patients were studied for an additional three weeks following the onset of the allergy season. Patients in two of the study arms received the active medication prior to the onset of the allergy season, and patients in the other two arms received only placebo during this period.
A total of 715 patients, aged 17 to 75, with a demonstrated multi-year history of sensitivity to Mountain Cedar pollen were randomized into 4 study arms, and 641 patients completed the study.
Chas Radovich, Cobalis CEO commented. “We are extremely pleased to announce these preliminary results of our first phase III Clinical Study of PreHistin, and especially pleased that the study arm of patients receiving only PreHistin fared best in achieving the lowest average symptom scores of all other arms.”
Cobalis expect to announce the final detailed results within the coming 4-6 weeks.