Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: 300 IR grass pollen allergen extract tablet
* Drug: Placebo tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients aged 5 to 17 years. Written consent / assent. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2). Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12. Exclusion Criteria: Patients who have received any desensitisation treatment for grass pollen.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 300 IR<br>300 IR grass pollen allergen extract tablet | Drug: 300 IR grass pollen allergen extract tablet<br>* One sublingual tablet daily during 4 months before pollen season and during pollen season<br>* Other names: Sublingual immunotherapy tablet;|
| Placebo Comparator: Placebo<br>Placebo tablet | Drug: Placebo tablet<br>* One sublingual tablet daily during 4 months before pollen season and during pollen season<br>* Other names: Sublingual placebo tablet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Rhinoconjunctivitis Total Symptom Score (ARTSS) | Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome. | Pollen period (average of 38.6 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis