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Corticosteroid

Early Steroid Treatment for Childhood Asthma (EASI-AS-ODT Trial)

Phase 4
Waitlist Available
Led By Jennifer Fishe, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
primary problem: Asthma exacerbation
transported by EMS to an ED
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (ed stay)
Awards & highlights

EASI-AS-ODT Trial Summary

This trial is testing whether giving a child with asthma a corticosteroid early on, before they arrive at the emergency room, will decrease hospital admissions, time in the ER, and time in the ICU.

Who is the study for?
This trial is for children with asthma who are stable enough to take oral medication and are being transported by EMS to an emergency department. It's not for kids allergic to prednisolone, those unconscious or critically ill, with chronic lung diseases other than asthma, airway abnormalities, tracheostomy, weakened immune systems, traumatic injuries, pregnant ones, in law enforcement custody or on daily corticosteroid therapy.Check my eligibility
What is being tested?
The study tests if giving steroids like Prednisolone early in the ambulance can help reduce hospital stays and intensive care visits for kids having a severe asthma attack. The trial will observe patients over three years across multiple EMS agencies to see how earlier treatment affects outcomes and costs.See study design
What are the potential side effects?
Prednisolone may cause side effects such as mood changes, increased appetite leading to weight gain, trouble sleeping (insomnia), heartburn or stomach irritation. Long-term use can lead to more serious issues like weakened bones.

EASI-AS-ODT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My primary issue is worsening asthma.
Select...
I was brought to the emergency department by ambulance.

EASI-AS-ODT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (ed stay)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (ed stay) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospital Admission
Secondary outcome measures
Emergency Department length-of-stay

EASI-AS-ODT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Prehospital Systemic CorticosteroidsExperimental Treatment1 Intervention
Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services
Group II: Usual CareActive Control1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisolone
2005
Completed Phase 4
~2720

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,850,190 Total Patients Enrolled
6 Trials studying Childhood Asthma
2,086 Patients Enrolled for Childhood Asthma
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
714,182 Total Patients Enrolled
Jennifer Fishe, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
38 Total Patients Enrolled

Media Library

Prednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03962894 — Phase 4
Childhood Asthma Research Study Groups: Early Prehospital Systemic Corticosteroids, Usual Care
Childhood Asthma Clinical Trial 2023: Prednisolone Highlights & Side Effects. Trial Name: NCT03962894 — Phase 4
Prednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03962894 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are offering the trial experiment?

"This medical trial is open for enrollment at 7 different sites, including Sarasota, Yulee and Houston. To reduce the burden of travel requirements, patients are invited to select a clinical centre near their home location."

Answered by AI

What risks do patients take on when taking Prednisolone?

"There is ample evidence supporting the safety of prednisolone, thus our team gave it a rating of 3. This drug is approved for use by regulatory bodies in numerous countries and has gone through multiple phases of clinical trials."

Answered by AI

Is the upper age limit of this trial restricted to those under 40 years old?

"This clinical trial is enrolling participants between 2 and 18 years of age. 74 studies require minors, while 60 are targeting seniors over 65."

Answered by AI

Does my profile fit the prerequisites for participating in this experiment?

"This study seeks to recruit 2500 participants aged 2-18 who have asthma and were transported by emergency personnel to an Emergency Department."

Answered by AI

What other research has explored the efficacy of Prednisolone?

"Presently, there are 87 active clinical trials exploring the uses of Prednisolone with 33 Phase 3 trials. Most studies involving this medication originate in Nanjing Jiangsu; however, research is being conducted across 2949 distinct sites globally."

Answered by AI

How many individuals are partaking in the experiment?

"Affirmative. Clinicaltrials.gov clearly details that since its initial posting on November 13th 2019, this clinical trial is actively enlisting 2500 volunteers from 7 different medical institutions."

Answered by AI

For which maladies is Prednisolone prescribed?

"Prednisolone is a very effective treatment for allergic contact dermatitis, nephrotic syndrome, and vasculitis."

Answered by AI

Is enrollment for this trial still open?

"According to clinicaltrials.gov, this medical trial is still enrolling subjects as of December 7th 2021 - having first been posted on November 13th 2019."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Early Administration of Steroids in the Ambulance Setting
2019. "Early Administration of Steroids in the Ambulance Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03962894.
~24 spots leftby May 2024
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