Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Inclusion Criteria:

• Written consent
• Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
• Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
• Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
• Safety laboratory resuts within the references ranges

Exclusion Criteria:

• Pregnancy, breast-feeding/lactation
• Had received desensitisation treatment for grass pollen
• Treatment by immunotherapy with another allergen within the previous 5 years
• Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
• Treated with beta-blockers or under continuous corticotherapy