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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Disease

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stallergenes Sa, Antony, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female outpatients aged 12 to 65 years (inclusive).
Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
Positive SPT
RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

Exclusion criteria

Positive SPT to any other seasonal allergens present during the grass pollen season
Patients with clinically significant confounding symptoms of allergy to other allergens
Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).

Treatment and study plan

300 IR

Drug

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

Other names: Sublingual immunotherapy tablet

Placebo

Drug

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

Other names: Sublingual placebo tablet

Primary outcomes

Average Adjusted Symptom Score (AAdSS)

Time frame: Pollen period (average of 32.1 days)

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.

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Dec 5, 2008
Registry last updated: May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed