Conditions: Allergic Rhinitis Due to Dust Mite
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 471
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 300 IR house dust mites allergen extract tablet arm 2: Placebo tablet

Interventions: intervention 1: 300 IR house dust mites allergen extract tablet intervention 2: Placebo tablet
Intervention descriptions: intervention 1: One sublingual tablet daily for one year. intervention 2: One sublingual tablet daily for one year.

Protocol document: