Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-02-02 @ 2:20 PM
Study NCT ID:
NCT03788395
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2018-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-05', 'studyFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Adherence Rating Scale (MARS)', 'timeFrame': '3 months', 'description': 'Change in the MARS score from baseline to the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Childhood Asthma Control Test (C-ACT)', 'timeFrame': '3 months', 'description': 'Change in the C-ACT score from baseline to the end of treatment'}, {'measure': 'Asthma Control Test (ACT)', 'timeFrame': '3 months', 'description': 'Change in the ACT score from baseline to the end of treatment'}, {'measure': 'Pediatric Asthma Quality of Life Questionnaire (PAQLQ)', 'timeFrame': '3 months', 'description': 'Change in the PAQLQ score from baseline to the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '35691614', 'type': 'DERIVED', 'citation': 'Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.\n\nIn this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.\n\nThe present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- uncontrolled mild or moderate persistent asthma;\n\nExclusion Criteria:\n\n* acute upper respiratory infections;\n* immunological or metabolic systemic disease;\n* major malformations of the upper airways;\n* active smokers.'}, 'identificationModule': {'nctId': 'NCT03788395', 'briefTitle': 'The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma', 'orgStudyIdInfo': {'id': '10/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symbicort Turbohaler plus Turbo+', 'description': '10 asthmatic children', 'interventionNames': ['Device: Symbicort Turbohaler plus Turbo+']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symbicort Turbohaler without Turbo+', 'description': '10 asthmatic children', 'interventionNames': ['Drug: Symbicort Turbohaler without Turbo+']}], 'interventions': [{'name': 'Symbicort Turbohaler plus Turbo+', 'type': 'DEVICE', 'description': 'Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.', 'armGroupLabels': ['Symbicort Turbohaler plus Turbo+']}, {'name': 'Symbicort Turbohaler without Turbo+', 'type': 'DRUG', 'description': 'Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.', 'armGroupLabels': ['Symbicort Turbohaler without Turbo+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90146', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council', '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': 'Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". 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"}}}}