Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-01 @ 1:29 PM
Study NCT ID:
NCT01103050
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Nasal Symptom Score measured during allergen exposure', 'timeFrame': '14 Days'}], 'secondaryOutcomes': [{'measure': 'Nasal airway patency assessed by acoustic rhinometry during allergen exposure', 'timeFrame': '14 days'}, {'measure': 'Nasal secretion weight during allergen exposure', 'timeFrame': '14 days'}, {'measure': 'Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure', 'timeFrame': '14 days'}]}, 'conditionsModule': {'keywords': ['Allergic inflammation', 'Seasonal rhinitis'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ers-education.org/home/browse-all-content.aspx?idParent=136559', 'label': 'Publication Link QAV680, cetirizine and their combination reduce nasal symptoms in patients with intermittent allergic rhinitis in an environmental exposure chamber'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons\n* positive skin prick test to ragweed allergen within twelve months of screening\n\nExclusion criteria:\n\n* Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes)\n* Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease\n* Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01103050', 'briefTitle': 'A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in an Environmental Exposure Chamber', 'orgStudyIdInfo': {'id': 'CQAV680A2204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'QAV680 + Cetirizine Placebo', 'interventionNames': ['Drug: QAV680 + Cetirizine Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'QAV680 + Cetirizine', 'interventionNames': ['Drug: QAV680 + Cetirizine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cetirizine + QAV680 Placebo', 'interventionNames': ['Drug: Cetirizine + QAV680 Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'QAV680 Placebo + Cetirizine Placebo', 'interventionNames': ['Drug: QAV680 Placebo + Cetirizine Placebo']}], 'interventions': [{'name': 'QAV680 + Cetirizine Placebo', 'type': 'DRUG', 'armGroupLabels': ['QAV680 + Cetirizine Placebo']}, {'name': 'QAV680 + Cetirizine', 'type': 'DRUG', 'armGroupLabels': ['QAV680 + Cetirizine']}, {'name': 'Cetirizine + QAV680 Placebo', 'type': 'DRUG', 'armGroupLabels': ['Cetirizine + QAV680 Placebo']}, {'name': 'QAV680 Placebo + Cetirizine Placebo', 'type': 'DRUG', 'armGroupLabels': ['QAV680 Placebo + Cetirizine Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}