Early Steroid Treatment for Childhood Asthma
(EASI-AS-ODT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if administering prednisolone (a type of steroid) earlier during an asthma attack can reduce hospital stays and improve outcomes for children. The focus is on children experiencing asthma attacks who are taken to the emergency room by ambulance. The trial will compare those who receive the medication in the ambulance to those who receive it later in the emergency room. Children who frequently experience asthma attacks and can swallow a pill while being transported by ambulance may be suitable for this study. As a Phase 4 trial, it involves an FDA-approved treatment and aims to understand how it can benefit more patients.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but if you are on daily or every other day corticosteroid therapy, you cannot participate.
What is the safety track record for prednisolone?
Studies have shown that medications like prednisolone, a type of steroid, are crucial for treating asthma in both children and adults. Research indicates that oral prednisolone can improve symptoms in young children with asthma or wheezing. Most children tolerate the medication well, and in many cases, the benefits outweigh the risks.
One study found that children who took prednisolone experienced better health outcomes, including easier breathing and fewer symptom recurrences. This suggests that the treatment is effective and manageable for children experiencing asthma attacks.
Prednisolone is commonly used to treat asthma flare-ups in hospitals and emergency rooms, with its use supported by international asthma guidelines. While all medications can have side effects, evidence shows that prednisolone is safe and effective for treating asthma in children.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about early steroid treatment for childhood asthma because it introduces systemic corticosteroids earlier in the treatment process, right when emergency medical services respond. This approach is different from the usual care, where steroids are typically given only once the child reaches the emergency department. By administering the steroids sooner, there's potential to reduce the severity of asthma attacks, possibly leading to quicker relief and fewer complications. This proactive strategy could change how emergency asthma care is managed, offering faster intervention that might improve outcomes for children experiencing severe asthma attacks.
What evidence suggests that early prehospital systemic corticosteroids are effective for childhood asthma?
Research has shown that administering corticosteroids (a type of anti-inflammatory medicine) to children with asthma sooner can relieve symptoms faster than waiting until they reach the emergency department (ED). In this trial, one group of children will receive systemic corticosteroids in the prehospital environment by emergency medical services. One study found that children who received these medicines earlier left the hospital sooner, with noticeable improvements in their condition. The chances of early discharge were seven times higher with early steroid use. Another study demonstrated that giving steroids within 75 minutes of arriving at the ED shortened hospital stays. Overall, early administration of corticosteroids seems to help children with asthma recover faster and avoid longer hospital visits.35678
Who Is on the Research Team?
Jennifer Fishe, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prehospital Treatment
Children with asthma attacks receive systemic corticosteroids in the prehospital environment by emergency medical services
Emergency Department Treatment
Children with asthma attacks receive usual care en route to emergency departments, where they then receive systemic corticosteroids
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prednisolone
Prednisolone is already approved in European Union, United States, Canada, Japan for the following indications:
- Asthma
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Multiple sclerosis
- Polymyalgia rheumatica
- Giant cell arteritis
- Asthma
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Multiple sclerosis
- Polymyalgia rheumatica
- Giant cell arteritis
- Asthma
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Multiple sclerosis
- Polymyalgia rheumatica
- Giant cell arteritis
- Asthma
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Multiple sclerosis
- Polymyalgia rheumatica
- Giant cell arteritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator