Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Greer has completed enrollment for its pivotal Phase III clinical trial designed to study the efficacy of sublingual-oral immunotherapy as a treatment for adults with allergic rhinoconjunctivitis caused by short ragweed pollen.
Subscribe to our email newsletter
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.”