A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase III study to assess the long term efficacy, carry-over effect and safety of two dosing regimens of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis

• Conditions: grass pollen rhinoconjunctivitis; MedDRA version: 8.1Level: PTClassification code 10039085Term: Rhinitis allergic

• Registration Number: EUCTR2006-003258-98-AT
• Lead Sponsor: Stallergenes S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• Male or female outpatients aged 18 to 50 years (inclusive).
• Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
• Sensitised to grass pollen (positive skin prick test and IgE level of at least Class 2).
• Total symptom score on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) during the previous pollen season of greater than or equal to 12 out of a possible score of 18.
• Female patients of childbearing potential must be willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy for the first 3 years of this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen may not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
• Asthma requiring treatment other than beta-2 inhaled agonists.
• Patients who have received desensitisation treatment for grass pollen.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified