Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

Allergy Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409409
• Other study ID #: VO52.06
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2006
• Last updated: September 28, 2011
• Start date: December 2006
• Est. completion date: August 2007

Study information

• Verified date: September 2011
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesGermany: Paul-Ehrlich-InstitutPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Male or female outpatients aged 5 to 17 years.

• Written consent / assent.

• Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.

• Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).

• Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion Criteria:

• Patients who have received any desensitisation treatment for grass pollen.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• Sublingual immunotherapy tablets of grass pollen allergen extract

Locations

Country	Name	City	State
Germany	Charité - Campus Virchow Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of SLIT for grass pollen allergens on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.
Secondary	To assess the efficacy of SLIT for grass pollen allergens on the rescue medication score and usage and to document the safety of the treatment.