Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Inclusion Criteria:

• A history of birch pollen allergy
• Positive skin prick test to birch
• Positive conjunctival test to birch
• Positive specific Immunoglobulin E (IgE) to birch

Exclusion Criteria:

• Forced expiratory volume in 1 second (FEV1)<70% of predicted value
• History of seasonal allergy interfering with study
• History of symptomatic perennial allergy
• History of emergency visit or admission for asthma in the previous 12 month