Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

In this pivotal, multicentre, international, randomized, double-blind, placebo and active-comparator controlled, parallel study, 683 patients with SAR will be enrolled. Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test, total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.

Inclusion criteria

• Patients of either sex between 12 and 70 years of age.
• Patients with documented clinical history of SAR, for at least 2 years prior to the study inclusion.
• Positive skin prick test for at least one of the seasonal allergen specific of the geographical area.
• A previous positive Prick test, or a positive IgE Test (RAST) may also be accepted for inclusion, if performed within 12 months prior to the inclusion.

Exclusion criteria

• Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.).
• Negative skin prick test (as defined in point 6.1.1.).
• Patients with nasal polyps or a significant deviation of the nasal septum as judged by the investigator as well as nasal intervention in the previous 6 months. Any other nasal illness that can interfere with the aim of the study.
• Patients who have acute or chronic sinusitis as judged by the investigator.
• Patients who have received anti-allergy immunotherapy in the previous two years or are still receiving this kind of therapy.
• Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period