Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Phase 3CompletedNCT00367640

Stallergenes Greer628 enrolled

Overview

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

628

Conditions

Allergy

Interventions

100 IR grass pollen allergen extract tabletDRUG

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

300 IR grass pollen allergen extract tabletDRUG

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

500 IR grass pollen allergen extract tabletDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written consent * Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons. * Sensitised to grass pollen (positive SPT and RAST level of at least class 2). * Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12. * Safety laboratory resuts within the references ranges Exclusion Criteria: * Pregnancy, breast-feeding/lactation * Had received desensitisation treatment for grass pollen * Treatment by immunotherapy with another allergen within the previous 5 years * Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies * Treated with beta-blockers or under continuous corticotherapy

Outcomes

Primary Outcomes

Average Rhinoconjunctivitis Total Symptom Score

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 32 days in the ITT set)

Data from ClinicalTrials.gov

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