Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis (With or Without Asthma)

Primary Disease Clinical Trial

Official title: A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT), Starting 2 Months Before the Grass Pollen Season, Administered as Allergen Based Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis (With or Without Asthma)

Status Completed

Clinical Trial 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.

Clinical Trial 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).

• The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.

• The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid).

• The Average Combined Score (ACS). A score taking into account the RTSS and Rescue Medication Score (RMS).

• Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS).

• The proportion of symptom-controlled days (PSCD).

• The global evaluation of the efficacy of sublingual tablets of grass pollen allergen extract by the patient.

To document the safety of the treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Primary Disease

• NCT number: NCT00803244
• Study type: Interventional
• Source: Stallergenes
• Status: Completed
• Phase: Phase 3
• Start date: January 2009
• Completion date: January 2010