159 Participants NeededMy employer runs this trial

Dexamethasone vs Methylprednisolone for Asthma

(PATCH Trial)

MS
Overseen ByMeghan Sorondo, PharmD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Johns Hopkins All Children's Hospital
Must be taking: Systemic corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective steroid treatment for children hospitalized with severe asthma attacks. It compares three different steroid dosing schedules to identify which one reduces the need for additional medication and improves the patient's quality of life. Children hospitalized in the intensive care unit for critical asthma are suitable candidates for this study. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important research.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both dexamethasone and methylprednisolone are generally safe and effective for treating asthma in children. Studies have found dexamethasone to be safe and effective, with various doses yielding positive results for kids with asthma. Specifically, one study found that children using dexamethasone for severe asthma experienced good safety outcomes, making it a reliable choice.

Regarding methylprednisolone, research also supports its safety for asthma treatment. Studies comparing it to other anti-inflammatory medicines found it to be equally safe and effective. The FDA has approved methylprednisolone for treating asthma, further supporting its safety.

In summary, both treatments have been successfully used in children with asthma and maintain strong safety records.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for asthma because they offer different dosing schedules that could improve patient convenience and outcomes. Dexamethasone is being tested in two dosing regimens: once daily and every 6 hours, both for just two days, which could make it more convenient compared to the traditional longer courses of steroids like prednisone. Methylprednisolone, on the other hand, is being administered every 6 hours for five days, offering another option for those who may benefit from a more sustained regimen. These variations in dosing could provide more tailored treatment options, potentially leading to better management of asthma symptoms with fewer side effects.

What evidence suggests that this trial's treatments could be effective for asthma?

This trial will compare different dosing regimens of Dexamethasone and Methylprednisolone for managing asthma flare-ups. Research has shown that Dexamethasone effectively manages asthma flare-ups, with studies indicating that a single dose can work as well as taking other steroids like prednisolone over a longer period. In this trial, participants may receive Dexamethasone once daily or every 6 hours. Methylprednisolone, another treatment option in this trial, has significantly improved asthma symptoms, especially in severe cases where higher doses are often used. However, some studies found no clear advantage of very high doses over standard ones. Both treatments are strongly supported by evidence for effectively reducing asthma symptoms.16789

Who Is on the Research Team?

MS

Meghan Sorondo, PharmD

Principal Investigator

Johns Hopkins All Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 3-17 years who are hospitalized in the intensive care unit due to severe asthma attacks. Kids with certain heart defects, cystic fibrosis, or those needing a breathing tube (tracheostomy) can't join.

Inclusion Criteria

I have been admitted to an intensive care unit.
I am between 3 and 17 years old.
I am being treated for severe asthma.

Exclusion Criteria

History of unrepaired critical congenital heart disease
I have been diagnosed with cystic fibrosis.
I currently depend on a tracheostomy to breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Dexamethasone or Methylprednisolone for critical asthma management

5 days
Daily in-person visits for medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments

30 days
1 visit (in-person) at 30 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
  • Methylprednisolone

Trial Overview

The study compares three steroid treatments for severe asthma: once-daily dexamethasone, dexamethasone every 6 hours, and methylprednisolone every 6 hours. Children are randomly assigned to one of these groups.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: Dexamethasone Once Daily Dosing for 2daysActive Control1 Intervention
Group II: Dexamethasone Every 6-Hours Dosing for 2 daysActive Control1 Intervention
Group III: Methylprednisolone Every 6-hours Dosing for 5-daysActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins All Children's Hospital

Lead Sponsor

Trials
47
Recruited
5,009,000+

Citations

Comparative effectiveness of oral dexamethasone vs ... - PMC

This study will throw some light on the effectiveness of oral dexamethasone as compared with oral prednisolone for acute exacerbation of asthma in children.

Evaluation of Dexamethasone Dosing Strategies in Pediatric ...

A standardized dosing strategy for dexamethasone in pediatric asthma exacerbations showed favorable outcomes and may lead to improved adherence.

Comparison of Oral Dexamethasone Doses in Asthma ...

Given the long half life of dexamethasone, the investigators hypothesized that 2 doses given on days 1 and 3 are superior to single dose in improving symptoms ...

Adoption of Dexamethasone for Asthma Exacerbations

Previous work has demonstrated that dexamethasone has similar efficacy to prednisolone/prednisone for the management of asthma exacerbations ...

Dexamethasone for Asthma

The objective was to determine whether 2 days of oral dexamethasone (DEX) is more effective than 5 days of oral prednisone/prednisolone (PRED) ...

Dexamethasone Treatment Regimen and Clinical ...

These results suggest that 1 dose of dexamethasone may be sufficient to treat many children with asthma exacerbations discharged from the ED.

Dexamethasone Versus Prednisolone in Acute ...

Because of insufficient local comparative data, this study was designed to determine the outcome of intravenous dexamethasone in contrast to ...

Dexamethasone Is a Safe, Effective Alternative to ...

“In this trial, children hospitalised for critical asthma receiving intravenous dexamethasone 0.25 mg/kg every 6 hours for 48 hours ...

Methylprednisolone, Dexamethasone, or Hydrocortisone ...

This study suggests that methylprednisolone, hydrocortisone, and dexamethasone are equally safe and efficacious, which would allow intensivists to tailor the ...