Asthma AcuteNCT07412769
ASMact: Study on Management of Bronchial Asthma
An observational study of Asthma Acute and Asthma Childhood, run by Meyer Children's Hospital IRCCS at 2 sites in Italy.
Trial summary
Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma Acute, Asthma Childhood, Asthma in Children
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- 5 Nov 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Arcispedale S. Anna
Ferrara, FE, 44124
Luca Di Napoli, MD
- Recruiting
Meyer Children's Hospital IRCCS, Firenze
Florence, 50134
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma Acute, Asthma Childhood, Asthma in Children, Asthma Crisis
- Keywords
- asthma attack, exacerbation,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Pre-intervention and through study completion, an average of 9 months
Percentage of patients with correct follow-up at discharge
Measured: Pre-intervention and through study completion, an average of 9 months
Percentage of patients in whom additional drugs are used in refractory cases
Measured: Pre-intervention and through study completion, an average of 9 months
Percentage of patients with correct therapy at discharge
Measured: Pre-intervention and through study completion, an average of 9 months
Secondary 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.
Measured: Pre-intervention and through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start5 Nov 2025
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grazia Fenu, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412769
- Sponsor's protocol ID
- ASMact
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT07412769
- Acronym / sponsor ID
- ASMact
- Conditions
- Asthma Acute, Asthma Childhood, Asthma in Children, Asthma Crisis
- Keywords
- asthma attack, exacerbation,
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Percentage of patients with correct follow-up at discharge
Time frame: Pre-intervention and through study completion, an average of 9 months
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
Percentage of patients with correct therapy at discharge
Time frame: Pre-intervention and through study completion, an average of 9 months
1 secondary outcome
Incidence of acute asthma exacerbations
Time frame: Pre-intervention and through study completion, an average of 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Acute and Asthma Childhood, run by Meyer Children's Hospital IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grazia Fenu (+390555662388 ext. +390555662388, grazia.fenu@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.