The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.
After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months. An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
471
One sublingual tablet daily for one year.
One sublingual tablet daily for one year.
Average Adjusted Symptom Score (AASS) During the Treatment Period
The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake
Time frame: Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period
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