Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Stallergenes Greer381 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: \- The Average Adjusted Symptom Score (AASS). To document the safety of the treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

381

Conditions

Primary Disease

Interventions

300 IRDRUG

300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season

PlaceboDRUG

Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Male or female outpatients aged 12 to 65 years (inclusive). 2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons. 3. Positive SPT 4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18. Exclusion Criteria: 1. Positive SPT to any other seasonal allergens present during the grass pollen season 2. Patients with clinically significant confounding symptoms of allergy to other allergens 3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed. 4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma \[GINA\] 3 or 4).

Locations (6)

Stallergenes Sa

Antony, France

Hop Montauban

Montauban, France

Cab medical

Orange, France

Azienda Ospedaliera

Parma, Italy

Complejo Hospitalario de Caceres

Outcomes

Primary Outcomes

Average Adjusted Symptom Score (AAdSS)

The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use. Participants assessed daily, during the pollen period while on treatment, 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). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome.

Time frame: Pollen period (average of 32.1 days)

Data from ClinicalTrials.gov

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