ASMact: Study on Management of Bronchial Asthma

NCT07412769 | Recruiting DMC

• 1 other identifier: ASMact
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Asthma Acute; Asthma Childhood; Asthma in Children; Asthma Crisis

Keywords

asthma attack, exacerbation,

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Incidence of acute asthma exacerbations

  Pre-intervention and through study completion, an average of 9 months

Study Arms (2)

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)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (2)

Arcispedale S. Anna

Ferrara, FE, 44124, Italy

RECRUITING

Meyer Children's Hospital IRCCS, Firenze

Florence, 50134, Italy

RECRUITING

Central Study Contacts

Grazia Fenu

CONTACT

+390555662388; grazia.fenu@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 17, 2026
• Study Start: November 5, 2025
• Primary Completion: May 31, 2026
• Study Completion: June 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)