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: 14.1Level: PTClassification code 10039085Term: Rhinitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2006-003258-98-IT
• Lead Sponsor: STALLERGENES SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-29
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 633

Inclusion Criteria

Male or female outpatients aged 18 to 50 years (inclusive). Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. Positive SPT (wheal diameter greater than 3 mm) and specific IgE values of at least Class 2 for grass pollen allergens. A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS). (Evaluation of the most severe symptoms during the previous pollen season). 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: 0
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 must 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 any desensitisation treatment for grass pollen. Treatment by immunotherapy with any other allergen within the previous 5 years or ongoing.

Study & Design

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