ASMact: Study on Management of Bronchial Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorMeyer Children's Hospital IRCCS
About this trial
Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 6 and 17 years
Presentation to the emergency department with a diagnosis of acute asthma exacerbation
Evaluation in the emergency department of one of the participating centers during the study periods
Disqualifiers
Age < 6 years or > 17 years
Diagnosis other than acute asthma exacerbation
Incomplete or missing clinical data
Patients transferred from other hospitals already treated for the same episode
Trial population
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. Eligible 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Pre-intervention cohort
Group B: Post-intervention cohort
Trial outcomes
Primary outcomes
1
Change in the number of correctly reported diagnoses before and after intervention
Assessment of adherence to guideline-based diagnostic and therapeutic management of pediatric patients presenting with acute asthma exacerbations in the emergency department.
Time frame
Pre-intervention and through study completion, an average of 9 months2
Percentage of patients with correct timing, dosage, and method of drug administration before and after intervention
Time frame
Pre-intervention and through study completion, an average of 9 months3
Percentage of patients with correct follow-up at discharge
Time frame
Pre-intervention and through study completion, an average of 9 months4
Percentage of patients in whom additional drugs are used in refractory cases
Time frame
Pre-intervention and through study completion, an average of 9 monthsSecondary outcomes
1
Incidence of acute asthma exacerbations
Number of emergency department visits for acute asthma exacerbations among pediatric patients during the pre- and post-intervention periods.
Time frame
Pre-intervention and through study completion, an average of 9 monthsSponsors and contacts
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Source ClinicalTrials.gov