Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504933
• Other study ID #: BILA 1704/RAE
• Secondary ID: 2004-004586-14
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2007
• Last updated: April 4, 2012
• Start date: May 2005
• Est. completion date: November 2005

Study information

• Verified date: April 2012
• Source: Faes Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentRomania: National Medicines AgencyCzech Republic: State Institute for Drug ControlPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• bilastine
20 mg (encapsulated) tablets QD/14days
• Cetirizine
10 mg (encapsulated) tablets. QD/14 days
• Placebo
(encapsulated) Tablets QD/14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faes Farma, S.A.

References & Publications (4)

Bousquet J, Ansótegui I, Canonica GW, Zuberbier T, Baena-Cagnani CE, Bachert C, Cruz AA, González SN, Kuna P, Morais-Almeida M, Mullol J, Ryan DP, Sánchez-Borges M, Valiente R, Church MK. Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: evidence review. Curr Med Res Opin. 2012 Jan;28(1):131-9. doi: 10.1185/03007995.2011.648263. Epub 2011 Dec 22. Review. — View Citation

Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11. Review. Erratum in: Expert Opin Drug Saf. 2012 Jan;11(1):175. — View Citation

Jáuregui I, García-Lirio E, Soriano AM, Gamboa PM, Antépara I. An overview of the novel H1-antihistamine bilastine in allergic rhinitis and urticaria. Expert Rev Clin Immunol. 2012 Jan;8(1):33-41. doi: 10.1586/eci.11.87. Review. — View Citation

Kuna P, Bachert C, Nowacki Z, van Cauwenberge P, Agache I, Fouquert L, Roger A, Sologuren A, Valiente R; Bilastine International Working Group. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.		14 days	No
Secondary	AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.		14 days	No
Secondary	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.		14 days	No
Secondary	Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.			No
Secondary	Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14			No
Secondary	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			No