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NCT Number: NCT07412769

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.

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Key information

Conditions

Asthma Acute Asthma Childhood Asthma Crisis Asthma in Children

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arcispedale S. Anna, Ferrara, FE, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in the number of correctly reported diagnoses before and after intervention

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

    Assessment of adherence to guideline-based diagnostic and therapeutic management of pediatric patients presenting with acute asthma exacerbations in the emergency department.

  2. 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 months

  3. Percentage of patients with correct follow-up at discharge

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

  4. Percentage of patients in whom additional drugs are used in refractory cases

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

  5. Percentage of patients with correct therapy at discharge

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

Secondary outcomes

  1. Incidence of acute asthma exacerbations

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

    Number of emergency department visits for acute asthma exacerbations among pediatric patients during the pre- and post-intervention periods.

Study contacts

Contact information is provided by the study sponsor or research team.

Grazia Fenu

CONTACT

[email protected]

+390555662388 ext. +390555662388

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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