Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-11 @ 7:35 AM
Study NCT ID:
NCT00504933
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2007-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}, {'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C445659', 'term': 'bilastine'}, {'id': 'D017332', 'term': 'Cetirizine'}], 'ancestors': [{'id': 'D006919', 'term': 'Hydroxyzine'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 683}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-04', 'studyFirstSubmitDate': '2007-07-19', 'studyFirstSubmitQcDate': '2007-07-19', 'lastUpdatePostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.", 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': "AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.", 'timeFrame': '14 days'}, {'measure': '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.', 'timeFrame': '14 days'}, {'measure': 'Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.'}, {'measure': 'Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14'}, {'measure': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhinitis', 'Allergic', 'Seasonal', 'Hay Fever', 'Pollen Allergy', 'Pollinosis', 'Rhinoconjunctivitis'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '22149770', 'type': 'BACKGROUND', '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.'}, {'pmid': '21831011', 'type': 'BACKGROUND', '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.'}, {'pmid': '22149338', 'type': 'BACKGROUND', '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.'}, {'pmid': '19438584', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either sex between 12 and 70 years of age.\n* Patients with documented clinical history of SAR, for at least 2 years prior to the study inclusion.\n* Positive skin prick test for at least one of the seasonal allergen specific of the geographical area.\n* 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.\n\nExclusion Criteria:\n\n* Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.).\n* Negative skin prick test (as defined in point 6.1.1.).\n* 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.\n* Patients who have acute or chronic sinusitis as judged by the investigator.\n* Patients who have received anti-allergy immunotherapy in the previous two years or are still receiving this kind of therapy.\n* Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period'}, 'identificationModule': {'nctId': 'NCT00504933', 'briefTitle': 'Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Faes Farma, S.A.'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'BILA 1704/RAE'}, 'secondaryIdInfos': [{'id': '2004-004586-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Bilastine', 'interventionNames': ['Drug: bilastine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Cetirizine', 'interventionNames': ['Drug: Cetirizine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'bilastine', 'type': 'DRUG', 'description': '20 mg (encapsulated) tablets QD/14days', 'armGroupLabels': ['A']}, {'name': 'Cetirizine', 'type': 'DRUG', 'otherNames': ['Zyrtec'], 'description': '10 mg (encapsulated) tablets. QD/14 days', 'armGroupLabels': ['B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '(encapsulated) Tablets QD/14 days', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Piotr Kuna, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barlicki University Hospital, Medical University of Lodz (Poland)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faes Farma, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}