Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Seasonal Allergic Rhinitis	Drug: bilastine; Drug: Cetirizine; Drug: Placebo	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	683 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	May 2005
Actual Primary Completion Date :	November 2005
Actual Study Completion Date :	November 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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 Name: Zyrtec
Placebo Comparator: C; Placebo	Drug: Placebo; (encapsulated) Tablets QD/14 days

Outcome Measures

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Primary Outcome Measures :

1. 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 Measures :

1. AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms. [ Time Frame: 14 days ]
2. 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 ]
3. Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.
4. Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14
5. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Faes Farma, S.A.

Investigators

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

More Information

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Publications of Results:

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.

Other Publications:

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.

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.

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.

Responsible Party:	Faes Farma, S.A.
ClinicalTrials.gov Identifier:	NCT00504933 History of Changes
Other Study ID Numbers:	BILA 1704/RAE; 2004-004586-14 ( EudraCT Number )
First Posted:	July 20, 2007
Last Update Posted:	April 5, 2012
Last Verified:	April 2012

Keywords provided by Faes Farma, S.A.:

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

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity	Immune System Diseases; Cetirizine; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs