Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

April 4, 2012 updated by: Faes Farma, S.A.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

683

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: C
Placebo
Drug: Placebo
(encapsulated) Tablets QD/14 days
Experimental: A
Bilastine
Drug: bilastine
20 mg (encapsulated) tablets QD/14days
Active Comparator: B
Cetirizine
Drug: Cetirizine
10 mg (encapsulated) tablets. QD/14 days
Other Names:
  • Zyrtec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.
Time Frame: 14 days
14 days
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.
Time Frame: 14 days
14 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faes Farma, S.A.

Investigators

  • Principal Investigator: Piotr Kuna, Prof. Dr, Barlicki University Hospital, Medical University of Lodz (Poland)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BILA 1704/RAE
  • 2004-004586-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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