A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model

Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge

时间窗: 6 months

The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS_0-4h. A decrease in the AUCRTSS_0-4h value represents relief from the HDM allergic symptoms.