Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Allergic Rhinitis Due to Dust Mite

Intervention / Treatment
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* Drug: Dpte and Dfar Allergen Extracts
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients, aged 5-17 years inclusive History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s) Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L) 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 patients sensitised to cat or dog allergens and regularly exposed to these allergens patients sensitised to aspergillus, cladosporium, alternaria patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dpte and Dfar Allergen Extract<br> | Drug: Dpte and Dfar Allergen Extracts<br>* 300 IR, once a day, for one year.<br>* Other names: Dermatofagoides Farinae;|
| Placebo Comparator: Placebo tablets<br> | Drug: placebo<br>* once a day, for one year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Assessment | Evaluation of the Average Adjusted Symptom Score (AASS) during the treatment period | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Assessment at the end of the treatment phase and at the end of the Treatment free follow up phase | AASS, ARTSS (average rhinitis total symptom score), ARMS (average rescue medication score),ARSS (individual average rhinoconjunctivitis symptom score), RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire Score), Safety | 60 months |