December 6, 2011
After a successful spring and summer recruiting eligible patients, the GRASS (Gauging Response in Allergic Rhinitis to Sublingual and Subcutaneous Immunotherapy) study now begins the enrollment phase of the trial and accrual is ahead of schedule.
As of November 2011, 55 subjects have enrolled and completed Visit -2, which involves the long 10-hour nasal allergen challenge procedure. The study started the randomization and treatment period in October, and 11 participants have been randomized to date.
GRASS is a randomized, double-blind, placebo-controlled, three-arm study comparing SLIT with placebo and SCIT with placebo. The ITN study is being conducted at a single-center led by Dr. Stephen Durham at Imperial College in London. Individuals with severe grass pollen hay fever were screened during the pollen season of March through September 2011. Eligible participants will be randomized to one of the following treatment arms administered in a double-blind, double-dummy fashion in a 1:1:1 ratio:
Participants will receive treatment over a two-year period, with a one-year blinded withdrawal phase. They will be provided with anti-allergic rescue medications (antihistamine, topical intranasal corticosteroids, and short-acting beta agonists) throughout the study. Clinical endpoint assessments will be performed at baseline, after one and two years of treatment, and after the one-year withdrawal period at three years. The primary objective of this trial is to determine whether SLIT induces tolerance.
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