NCT00803244

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Disease

Interventions

Type	Name	Description
DRUG	300 IR	300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season
DRUG	Placebo	Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-08-01
• Completion: 2010-01-01
• First posted: 2008-12-05
• Last updated: 2016-05-25
• Results posted: 2016-05-25

Locations

6 sites across 3 countries: France, Italy, Spain