Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT00967967
Status:
SUSPENDED
Last Update Posted:
2013-05-27
First Post:
2009-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the Rhinitis Control Scoring System (RCSS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'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'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C121345', 'term': 'desloratadine'}, {'id': 'D000068656', 'term': 'Mometasone Furoate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'Awaiting results from sub analysis to decide if study continuesé', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-24', 'studyFirstSubmitDate': '2009-08-26', 'studyFirstSubmitQcDate': '2009-08-27', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS.', 'timeFrame': 'March to November 2009'}], 'secondaryOutcomes': [{'measure': 'The relationship between rhinitis control and asthma control.', 'timeFrame': 'March to November 2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['control', 'symptoms'], 'conditions': ['Asthma', 'Rhinitis']}, 'referencesModule': {'references': [{'pmid': '26867531', 'type': 'DERIVED', 'citation': 'Boulay ME, Boulet LP. The Rhinitis Control Scoring System: Development and validation. Am J Rhinol Allergy. 2016 Jan-Feb;30(1):54-9. doi: 10.2500/ajra.2016.30.4260.'}]}, 'descriptionModule': {'briefSummary': 'Many patients suffering from allergic rhinitis do not recognize or perceive their symptoms. Instruments have been developed to assess quality of life in rhinitis, asthma or both, but there is a need to develop validated tools or methods to assess rhinitis control among rhinitis and/or asthmatic patients. The aim of this study is to assess the discriminative and evaluative properties of the RCSS in asthmatic patients with allergic rhinitis.', 'detailedDescription': 'Allergic asthmatic subjects showing seasonal rhinitis symptoms will be recruited. The discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS will be evaluated as well as the relationship between rhinitis control and asthma control. RCSS will be completed at various time points during the seasonal allergic period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asthma\n* seasonal allergic rhinitis\n\nExclusion Criteria:\n\n* smoking\n* nasal polyposis'}, 'identificationModule': {'nctId': 'NCT00967967', 'acronym': 'RCSS', 'briefTitle': 'Validation of the Rhinitis Control Scoring System (RCSS)', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Validation of a Rhinitis Control Tool : the Rhinitis Control Scoring System (RCSS)', 'orgStudyIdInfo': {'id': 'CER 20389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mometasone furoate and desloratadine', 'description': 'Mometasone and desloratadine treatment', 'interventionNames': ['Drug: Medication Mometasone furoate and desloratadine']}], 'interventions': [{'name': 'Medication Mometasone furoate and desloratadine', 'type': 'DRUG', 'otherNames': ['Nasonex', 'Aerius'], 'description': 'One month treatment with both drugs', 'armGroupLabels': ['Mometasone furoate and desloratadine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut universitaire de cardiologie et de pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Louis-Philippe Boulet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professeur', 'investigatorFullName': 'Louis-Philippe Boulet', 'investigatorAffiliation': 'Laval University'}}}}