Overview

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