Asthma in ChildrenPhase 4EASI-AS-ODTNCT03962894
Early Administration of Steroids in the Ambulance Setting
A Phase 4 study testing Prednisolone in people with Asthma in Children, run by University of Florida at 7 sites in United States.
Trial summary
Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 834 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Apr 2019to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- primary problem: Asthma exacerbation
- stable to take an oral medication
- transported by EMS to an ED
Who cannot join
- unconscious, hemodynamically unstable, or critically ill -> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)
- daily or every other day corticosteroid therapy
- allergy to prednisolone or another corticosteroid
- chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Walton County EMS
DeFuniak Springs, Florida, 32433
Lee County Public Safety & Emergency Services
Fort Myers, Florida, 33905
Texas Children's Hospital / UT Houston
Houston, Texas, 77030
Sarasota County EMS
Sarasota, Florida, 34236
Leon County EMS
Tallahassee, Florida, 32301
Nassau County Fire Rescue Department
Yulee, Florida, 32097
About this study
Official title: Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival.
Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation design in multiple EMS agencies, we will enroll patients to analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.
- Conditions
- Asthma in Children
- Being tested
- Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival.
| Study group | Role | What they receive |
|---|---|---|
| Early Prehospital Systemic Corticosteroids | Experimental | Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services Receives: Drug: Prednisolone |
| Usual Care | No intervention | Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Admission
Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation
Measured: Day 1 (ED stay)
Secondary outcomes (1)
Emergency Department Length-of-stay
Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital)
Measured: Day 1 (from EMS arrival to ED disposition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Apr 2019
- Primary completion31 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Fishe, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962894
- Sponsor's protocol ID
- IRB201901351 -N-A
- Other IDs
- 1K23HL149991-01
- Acronym
- EASI-AS-ODT
- Status last verified
- Apr 2025
- First submitted
- 22 May 2019
- Last updated
- 8 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
- ClinicalTrials.gov ID
- NCT03962894
- Acronym / sponsor ID
- EASI-AS-ODT / IRB201901351 -N-A
- Conditions
- Asthma in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival.
Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation design in multiple EMS agencies, we will enroll patients to analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Prehospital Systemic Corticosteroids | Experimental | Drug: PrednisoloneChildren with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services |
| Usual Care | No intervention | –Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- primary problem: Asthma exacerbation
- stable to take an oral medication
- transported by EMS to an ED
Key exclusion criteria (4 listed)
- unconscious, hemodynamically unstable, or critically ill -> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)
- daily or every other day corticosteroid therapy
- allergy to prednisolone or another corticosteroid
- chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneDuring a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival. | Drug | Early Prehospital Systemic Corticosteroids |
Primary outcome
Hospital Admission
Time frame: Day 1 (ED stay)
Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation
1 secondary outcome
Emergency Department Length-of-stay
Time frame: Day 1 (from EMS arrival to ED disposition)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Jennifer Fishe, MD principal investigator
University of Florida
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone in people with Asthma in Children, run by University of Florida at 7 sites in United States.
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 4 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: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Admission (time frame: Day 1 (ED stay)). 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 8 May 2025.