NCT01731249

Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis

A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 574 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.

Conditions

• Hypersensitivity
• Allergic Rhinitis
• Allergic Conjunctivitis
• Seasonal Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years
BIOLOGICAL	Birch pollen allergen extract	Sublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2012-11-21
• Last updated: 2012-11-27

Locations

11 sites across 11 countries: Czechia, Denmark, Estonia, Finland, France, Germany, Latvia, Lithuania, Poland, Slovakia, Sweden