A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis
A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis
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.
Inclusion Criteria:
Exclusion Criteria:
• Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded