Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-06 @ 4:09 PM
Study NCT ID:
NCT03273933
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-05', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acquisition and maintenance of the control status', 'timeFrame': 'Once every 4 weeks, for 12 weeks', 'description': 'mean C-ACT score'}], 'secondaryOutcomes': [{'measure': 'Quality of life in asthma children', 'timeFrame': '12 weeks', 'description': 'PAQLQ score'}, {'measure': 'Adherence to asthma treatment', 'timeFrame': '12 weeks', 'description': 'MARS score'}, {'measure': 'Lung function: FEV1', 'timeFrame': '12 weeks', 'description': 'Forced expiratory volume in the first second'}, {'measure': 'Lung function: FVC', 'timeFrame': '12 weeks', 'description': 'Forced vital capacity'}, {'measure': 'Lung function: FEF 25-75', 'timeFrame': '12 weeks', 'description': 'Forced expiratory flow at 25-75%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. In the first study arm, a new application (DragONE) for iOS and Android will be only used for patient monitoring. In the second study arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every 4 weeks for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of moderate persistent asthma\n* Uncontrolled symptoms (C-ACT≤ 19)\n* Treated for at least 3 months\n* FEV1 between 60% and 90% of predicted value\n\nExclusion Criteria:\n\n* Symptoms of acute respiratory infection\n* Immunological or metabolic systemic disease\n* Major malformations of the upper airways\n* Active smoker'}, 'identificationModule': {'nctId': 'NCT03273933', 'acronym': 'DragONE', 'briefTitle': 'DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices', 'orgStudyIdInfo': {'id': '7/2017_B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 children with DragONE only', 'interventionNames': ['Device: DragONE']}, {'type': 'EXPERIMENTAL', 'label': '10 children with DragONE and SmartOne', 'interventionNames': ['Device: DragONE', 'Device: SmartOne']}], 'interventions': [{'name': 'DragONE', 'type': 'DEVICE', 'description': 'The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.', 'armGroupLabels': ['10 children with DragONE and SmartOne', '10 children with DragONE only']}, {'name': 'SmartOne', 'type': 'DEVICE', 'description': 'A little portable spirometer connected to DragONE allows daily PEF monitoring.', 'armGroupLabels': ['10 children with DragONE and SmartOne']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Istituto per la Ricerca e l'Innovazione Biomedica", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '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"}}}}