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Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

bilastine

Cetirizine

Placebo

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Pollinosis, Rhinoconjunctivitis

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Bilastine

Cetirizine

Placebo

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT00504933

First Posted

July 19, 2007

Last Updated

April 4, 2012

Sponsor

Faes Farma, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT00504933

Brief Title

Efficacy Study for the Symptomatic 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 Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Faes Farma, S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Pollinosis, Rhinoconjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

683 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Bilastine

Arm Title

Arm Type

Active Comparator

Arm Description

Cetirizine

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

bilastine

Intervention Description

20 mg (encapsulated) tablets QD/14days

Intervention Type

Drug

Intervention Name(s)

Cetirizine

Other Intervention Name(s)

Zyrtec

Intervention Description

10 mg (encapsulated) tablets. QD/14 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

(encapsulated) Tablets QD/14 days

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

14 days

Title

Time Frame

14 days

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Piotr Kuna, Prof. Dr

Organizational Affiliation

Barlicki University Hospital, Medical University of Lodz (Poland)

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

22149770

Citation

Bousquet J, Ansotegui I, Canonica GW, Zuberbier T, Baena-Cagnani CE, Bachert C, Cruz AA, Gonzalez SN, Kuna P, Morais-Almeida M, Mullol J, Ryan DP, Sanchez-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.

Results Reference

background

PubMed Identifier

21831011

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. Erratum In: Expert Opin Drug Saf. 2012 Jan;11(1):175.

Results Reference

background

PubMed Identifier

22149338

Citation

Jauregui I, Garcia-Lirio E, Soriano AM, Gamboa PM, Antepara 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.

Results Reference

background

PubMed Identifier

19438584

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 of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy. 2009 Sep;39(9):1338-47. doi: 10.1111/j.1365-2222.2009.03257.x. Epub 2009 May 4.

Results Reference

result

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Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

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