Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:34 PM
Study NCT ID:
NCT07412769
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASMact: Study on Management of Bronchial Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the number of correctly reported diagnoses before and after intervention', 'timeFrame': 'Pre-intervention and through study completion, an average of 9 months', 'description': 'Assessment of adherence to guideline-based diagnostic and therapeutic management of pediatric patients presenting with acute asthma exacerbations in the emergency department.'}, {'measure': 'Percentage of patients with correct timing, dosage, and method of drug administration before and after intervention', 'timeFrame': 'Pre-intervention and through study completion, an average of 9 months'}, {'measure': 'Percentage of patients with correct follow-up at discharge', 'timeFrame': 'Pre-intervention and through study completion, an average of 9 months'}, {'measure': 'Percentage of patients in whom additional drugs are used in refractory cases', 'timeFrame': 'Pre-intervention and through study completion, an average of 9 months'}, {'measure': 'Percentage of patients with correct therapy at discharge', 'timeFrame': 'Pre-intervention and through study completion, an average of 9 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute asthma exacerbations', 'timeFrame': 'Pre-intervention and through study completion, an average of 9 months', 'description': 'Number of emergency department visits for acute asthma exacerbations among pediatric patients during the pre- and post-intervention periods.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma attack, exacerbation,'], 'conditions': ['Asthma Acute', 'Asthma Childhood', 'Asthma in Children', 'Asthma Crisis']}, 'descriptionModule': {'briefSummary': 'Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.', 'detailedDescription': 'Patients aged 6 to 17 years presenting to the emergency department with an acute asthma exacerbation were included. Clinical outcomes were compared between a pre-intervention period (October 2024-May 2025) and a post-intervention period (October 2025-May 2026).\n\nBetween the two study periods, a structured educational intervention targeting medical and nursing staff was implemented. The intervention consisted of didactic lectures, clinical simulation sessions, case-based discussions, and the dissemination of updated diagnostic and therapeutic flowcharts based on the 2025 Global Initiative for Asthma (GINA) guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population consists of pediatric patients aged 6 to 17 years presenting to the emergency departments of two Italian tertiary-care hospitals (AOU IRCCS Meyer Children's Hospital in Florence and Arcispedale S. Anna in Ferrara) with an acute asthma exacerbation.\n\nEligible patients were identified through retrospective review of electronic medical records of all emergency department visits occurring during the predefined study periods. Patients were included if they received a discharge diagnosis consistent with acute asthma exacerbation or related conditions (e.g., bronchospasm, asthma attack, asthmatic bronchitis, wheezing).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 6 and 17 years\n* Presentation to the emergency department with a diagnosis of acute asthma exacerbation\n* Evaluation in the emergency department of one of the participating centers during the study periods\n\nExclusion Criteria:\n\n* Age \\< 6 years or \\> 17 years\n* Diagnosis other than acute asthma exacerbation\n* Incomplete or missing clinical data\n* Patients transferred from other hospitals already treated for the same episode\n* history of allergy to any drugs used in the protocol'}, 'identificationModule': {'nctId': 'NCT07412769', 'briefTitle': 'ASMact: Study on Management of Bronchial Asthma', 'organization': {'class': 'OTHER', 'fullName': "Meyer Children's Hospital IRCCS"}, 'officialTitle': 'Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.', 'orgStudyIdInfo': {'id': 'ASMact'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-intervention cohort', 'description': 'Pediatric patients aged 6-17 years presenting to the emergency department with an acute asthma exacerbation during the pre-intervention period (October 2024-May 2025). Patients received standard care according to local clinical practice prior to the implementation of the structured educational intervention.\n\nIntervention:\n\nNo intervention (standard of care)'}, {'label': 'Post-intervention cohort', 'description': 'Pediatric patients aged 6-17 years presenting to the emergency department with an acute asthma exacerbation during the post-intervention period (October 2025-May 2026), after the implementation of a structured educational intervention for emergency department staff.\n\nIntervention:\n\nEducational intervention (health care provider-directed)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'state': 'FE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Di Napoli, MD', 'role': 'CONTACT'}], 'facility': 'Arcispedale S. Anna', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '50134', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'facility': "Meyer Children's Hospital IRCCS, Firenze", 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'centralContacts': [{'name': 'Grazia Fenu', 'role': 'CONTACT', 'email': 'grazia.fenu@meyer.it', 'phone': '+390555662388', 'phoneExt': '+390555662388'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Meyer Children's Hospital IRCCS", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Grazia Fenu', 'investigatorAffiliation': "Meyer Children's Hospital IRCCS"}}}}