Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
This study has been completed.
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First received: December 7, 2006
Last updated: September 28, 2011
Last verified: September 2011
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.
Drug: Sublingual immunotherapy tablets of grass pollen allergen extract
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Further study details as provided by Stallergenes:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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.
|Study Start Date:||December 2006|
|Study Completion Date:||August 2007|
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