Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: bilastine (Drug); Cetirizine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Faes Farma, S.A.

Official(s) and/or principal investigator(s):
Piotr Kuna, Prof. Dr, Principal Investigator, Affiliation: Barlicki University Hospital, Medical University of Lodz (Poland)

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.

Official title: Double-Blind, Randomised, Placebo-Controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Cetirizine 10 mg for the Treatment of Seasonal Allergic Rhinitis.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.

Secondary outcome:

AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.

Change from baseline at day 7 and day 14 for the following: Patient-rated (reflective and instantaneous) and Investigator-rated (instantaneous; assessed during study visit) TSS, NSS, NNSS and change for each individual symptom.

Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.

Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14

Responders Rate: responders will be classified based on their TSS decrease from baseline: no responders (<25%), >25%<50%, >50%<75%, >75% and will be described by treatment group with their percentage

Detailed description: 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.

Minimum age: 12 Years. Maximum age: 70 Years. Gender(s): Both.

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

Starting date: May 2005
Ending date: November 2005
Last updated: December 12, 2007