Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

Phase 1CompletedNCT00619827

Stallergenes Greer89 enrolled

Overview

The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

300 IR grass pollen allergen extract tabletDRUG

300 IR grass pollen allergen extract tablet once daily during four months

Placebo tabletDRUG

Placebo tablet once daily during four months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female outpatients 18-50 years old * grass pollen rhinoconjunctivitis of at least 2 years. * positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening. * written consent * a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge) Exclusion Criteria: * Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study * Asthma requiring treatment other than short-acting beta-2 inhaled agonists. * Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.

Locations (1)

Allergy Center Vienna West, Vienna Challenge Chamber -

Vienna, Austria

Outcomes

Primary Outcomes

Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours

The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.

Time frame: 4 months

Data from ClinicalTrials.gov

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