ASMact: Study on Management of Bronchial Asthma

Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.

Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Asthma Acute; Asthma Crisis; Asthma Childhood

Detailed Description

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).

Between 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Grazia Fenu; Phone Number: +390555662388 +390555662388; Email: grazia.fenu@meyer.it

Study Locations

• Italy
  • Florence, Italy, 50134
    • Recruiting
    • Meyer Children's Hospital IRCCS, Firenze
  • FE
    • Ferrara, FE, Italy, 44124
      • Recruiting
      • Arcispedale S. Anna
      • Contact: Luca Di Napoli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• history of allergy to any drugs used in the protocol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pre-intervention cohort; 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. Intervention: No intervention (standard of care)
Post-intervention cohort; 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. Intervention: Educational intervention (health care provider-directed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-intervention and through study completion, an average of 9 months
Percentage of patients with correct timing, dosage, and method of drug administration before and after intervention		Pre-intervention and through study completion, an average of 9 months
Percentage of patients with correct follow-up at discharge		Pre-intervention and through study completion, an average of 9 months
Percentage of patients in whom additional drugs are used in refractory cases		Pre-intervention and through study completion, an average of 9 months
Percentage of patients with correct therapy at discharge		Pre-intervention and through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute asthma exacerbations	Number of emergency department visits for acute asthma exacerbations among pediatric patients during the pre- and post-intervention periods.	Pre-intervention and through study completion, an average of 9 months

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: asthma attack, exacerbation,
• Other Study ID Numbers: ASMact

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No