Between March and June 2008, 556 patients were screened for the randomized, double-blind, placebo-controlled trial, of which 430 were enrolled.
The participants will be observed at 31 clinical sites across the country. The trial will last approximately seven months, ending in mid-October 2008 to coincide with the completion of the short ragweed pollen season.
The treatment course will consist of daily, self-administered doses of Greer’s standardized short ragweed pollen extract or placebo using a metered dosing device developed specifically for the studies. Participants range in ages from 18-55 and have a history of moderate to severe allergic rhinoconjunctivitis attributable to short ragweed pollen for at least two years. Patients with a history of mild intermittent asthma were also selected.
Robert Esch, executive vice president of R&D at Greer, said: “This study is significant because it is the first large Phase III trial conducted in the US for the sublingual-oral administration of liquid allergenic extracts. It is vital to Greer’s efforts to bring an FDA-approved sublingual-oral immunotherapy treatment to the US.”