Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faes Farma, S.A.
• Treatments: Cetirizine

Criteria

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