Early Steroid Treatment for Childhood Asthma

(EASI-AS-ODT Trial)

Recruiting at 6 trial locations

Overseen By Jennifer Fishe, MD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must not be taking: Corticosteroids

Disqualifiers: Chronic lung disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

834 Participants Needed

Trial Summary

What is the purpose of this 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.

Research Team

Jennifer Fishe, MD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

My primary issue is worsening asthma.

I was brought to the emergency department by ambulance.

I can take pills by mouth without difficulty.

Exclusion Criteria

I am taking corticosteroids daily or every other day.

You are allergic to prednisolone or any other steroid medication.

I am critically ill and will receive standard emergency care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Prehospital Treatment

Children with asthma attacks receive systemic corticosteroids in the prehospital environment by emergency medical services

Immediate (Day 1)

1 visit (in-person)

Emergency Department Treatment

Children with asthma attacks receive usual care en route to emergency departments, where they then receive systemic corticosteroids

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Prednisolone

Trial Overview 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.

Participant Groups

Group I: Early Prehospital Systemic Corticosteroids Experimental Treatment 1 Intervention

Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services

Group II: Usual Care Active Control 1 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

Prednisolone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Prednisolone for:

• Asthma
• Rheumatoid arthritis
• Crohn's disease
• Ulcerative colitis
• Multiple sclerosis
• Polymyalgia rheumatica
• Giant cell arteritis

Approved in United States as Prednisolone for:

• Asthma
• Rheumatoid arthritis
• Crohn's disease
• Ulcerative colitis
• Multiple sclerosis
• Polymyalgia rheumatica
• Giant cell arteritis

Approved in Canada as Prednisolone for:

• Asthma
• Rheumatoid arthritis
• Crohn's disease
• Ulcerative colitis
• Multiple sclerosis
• Polymyalgia rheumatica
• Giant cell arteritis

Approved in Japan as Prednisolone for:

• Asthma
• Rheumatoid arthritis
• Crohn's disease
• Ulcerative colitis
• Multiple sclerosis
• Polymyalgia rheumatica
• Giant cell arteritis

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+