Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-03 @ 10:18 AM
Study NCT ID:
NCT02409550
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D001249', 'term': 'Asthma'}], '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'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CARATKids Italian language validation', 'timeFrame': '3 weeks', 'description': 'The main objective of the study is the assessment process of the tool CARATKids, in a scholastic children Italian population affected by coexisting asthma and allergic rhinitis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergic Rhinitis', 'Asthma', 'Children', 'Control'], 'conditions': ['Allergic Rhinitis', 'Asthma']}, 'descriptionModule': {'briefSummary': 'This project is an observational study for the Italian language validation of the CARATKids questionnaire investigating the asthma and coexisting allergic rhinitis control in children. 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.\n\nThe study will be completed in two medical examination, within 3-6 weeks of each other.\n\nCARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test) will be filled by each patient.\n\nThe main outcome is the Italian language validation of the CARATKids questionnaire investigating the coexisting asthma and allergic rhinitis control in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months\n* 12 \\< years old \\> 6\n\nExclusion Criteria:\n\n* Patients with asthma only or allergic rhinitis only, or younger or older than the targeted age group'}, 'identificationModule': {'nctId': 'NCT02409550', 'briefTitle': 'CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children', 'orgStudyIdInfo': {'id': '11/2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': '113 patients with concomitant asthma and allergic rhinitis', 'description': '113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.', 'interventionNames': ['Other: CARATKids Questionnaire']}], 'interventions': [{'name': 'CARATKids Questionnaire', 'type': 'OTHER', 'armGroupLabels': ['113 patients with concomitant asthma and allergic rhinitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90146', 'city': 'Palermo', 'state': 'Palermo', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology, IBIM', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The IPD collected will be available on May 2016.\n\nThe following participant data will be shared:\n\n* Asthma severity level\n* Asthma control level\n* Pulmonary function tests\n* Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefania La Grutta, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.', 'investigatorFullName': 'Stefania La Grutta, MD', 'investigatorAffiliation': "Istituto per la Ricerca e l'Innovazione Biomedica"}}}}