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

Stallergenes Greer278 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

278

Conditions

Allergy

Interventions

300 IR grass pollen allergen extract tabletDRUG

One sublingual tablet daily during 4 months before pollen season and during pollen season

Placebo tabletDRUG

One sublingual tablet daily during 4 months before pollen season and during pollen season

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Charité - Campus Virchow Klinikum

Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: Pollen period (average of 38.6 days)

Data from ClinicalTrials.gov

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