Birch pollen is a major cause of allergic rhinitis/allergic rhino-conjunctivitis in Europe and worldwide, with up to 100 million reported cases. Allergic rhinitis/allergic rhino-conjunctivitis (AR/ARC) is a chronic disorder of the upper airways that is caused by allergen exposure and the resulting inflammation of the nose and to a less extent, the eyes (allergic rhino-conjunctivitis). Rhinitis symptoms include sneezing, runny nose, nasal itching and nasal congestion and can be associated with conjunctivitis symptoms such as watery, red and/or itchy eyes. Current treatment are allergen avoidance, symptomatic pharmacotherapy, and Allergen Immunotherapy (AIT). However, avoidance measures are generally not effective. While symptomatic treatment can provide temporary relief from allergy symptoms, many patients remain uncontrolled.~The goal of this study is to demonstrate the clinical efficacy of an allergen immunotherapy (STALORAL Birch 300 IR) in children and adolescents from 5 to 17 years old with birch pollen-induced allergic rhinoconjunctivitis treated once daily pre- and co-seasonally over two consecutive birch pollen seasons on the average daily ARC Total Combined Score (TCS) during the season.~This study is a multi-national phase IIIb, double-blind, placebo-controlled study in which 699 participants will be enrolled in Europe for 20 months during two consecutive seasons.~Participants will begin STALORAL Birch 300 IR administration 4 months prior to the birch pollen season (pre-seasonal treatment) and continue taking it for the duration of the season (co-seasonal treatment). There will approximately be 5 months of a treatment-free period prior to the next 4-month pre-seasonal treatment period and co-seasonal treatment.~The analysis will be performed at the end of the Year 2.
Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and watery eyes). For several birch-allergic patients, allergic rhinoconjunctivitis occurs with an oral allergy syndrome.~The purpose of this study is to demonstrate the safety and efficacy of the study drug (STALORAL Birch 300 IR) in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, when treated before and during the pollen season.~Approximately 699 children will participate in this study. The study will be conducted worldwide in approximately 100 medical sites in about 14 countries. The total duration of the study will be approximately 20 months.