Sublingual-swallow immunotherapy (SLIT) with a standardized five-grass-pollen extract (drops and sublingual tablets) versus placebo in seasonal rhinitis

Background: Recent studies have demonstrated the efficacy of sublingual-swa llow immunotherapy (SLIT) in seasonal and perennial rhinitis. Sublingual ad ministration of solutions is not convenient for all patients. The aim of th e study was to evaluate the efficacy and safety of immunotherapy administer ed sublingually, initially as drops, and then as tablets during maintenance therapy. Methods: A total of 126 patients with grass-pollen seasonal rhinitis were i ncluded in this double-blind, randomized, placebo-controlled trial. During the progression of doses phase, the five-grass extract was given as subling ual drops from 1 to 100 IR/ml. Once the 100 IR dose was reached, the drops were replaced by a single 100-IR sublingual tablet per day. Results: Throughout the grass-pollen season, patients in the active treatme nt group had significantly lower (P<0.05) total conjunctivitis and ocular r edness scores. Rhinitis symptoms were not significantly different between t he two groups. Patients given the active treatment were significantly (P<0. 02) less likely to have asthma symptoms. The global medication score showed no significant. difference between the two groups. A highly significant di fference in favor of the active treatment group was seen in inhaled salbuta mol use (P<0.01). Conclusions: Clinical benefits achieved during the present study included s ignificant improvements in conjunctivitis symptoms and prevention of asthma symptoms. The overall safety profile of the active treatment (drops or tab lets) was good.