A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase IIIpaediatric study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT)administered as allergen-based tablets once daily to children suffering from grasspollen rhinoconjunctivitis

• Conditions: Grass Pollen Rhinoconjunctivitis; MedDRA version: 8.1Level: LLTClassification code 10039085Term: Rhinitis allergic

• Registration Number: EUCTR2006-003006-26-FR
• Lead Sponsor: Stallergenes S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Male or female patients aged 5 to 17 years (inclusive); outpatients.
2. Written consent / assent (as applicable).
3. Grass pollen-related allergic rhinoconjunctivitis for the last two pollen seasons.
4. Sensitised to grass pollen (positive skin prick test and grass pollen-specific IgE level of at least Class 2).
5. Total symptom score on the RRTSS during the previous pollen season of greater than or equal to 12.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The average RTSS (Rhinoconjunctivitis Total Symptom Score) while on treatment is the primary efficacy endpoint.;Main Objective: To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage.<br><br>To assess the efficacy of SLIT on the:<br>- Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms<br>sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.;Secondary Objective: To assess the efficacy of SLIT on the:<br>- Rescue medication usage (use of antihistamine, nasal topical treatment and systemic<br>corticosteroids).<br>- Combined Score - a score taking into account the RTSS and rescue medication usage.<br>- Six individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS).<br>- Proportion of symptom-free days.<br>- Global evaluation of the efficacy of SLIT by the patient.<br><br>To document the safety of the treatment.