Intramuscular Steroids for Asthma

(GASPING Trial)

Overseen By Mustfa Manzur, MD MPH MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must not be taking: Systemic corticosteroids

Disqualifiers: Heart failure, Uncontrolled diabetes, 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

Compensation: Varies

Number of Visits: 3

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for asthma flare-ups to determine which is more effective. One group receives a single injection of dexamethasone (a type of corticosteroid), while the other takes prednisone pills (also a corticosteroid) for five days. The goal is to determine if the one-time injection is as effective as the daily pills. This approach may suit adults who recently experienced an asthma attack and received treatment in the emergency room. Participants must speak English or Spanish. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, aiming to understand how they benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial requires that you are not currently using systemic corticosteroids before arriving at the emergency department. If you are taking other medications, the trial information does not specify whether you need to stop them.

What is the safety track record for these treatments?

Research has shown that a single injection of dexamethasone into a muscle is generally well-tolerated for asthma flare-ups. One study found that this single injection was as effective as taking oral prednisone for five days in treating mild to moderate asthma, offering a good alternative with similar safety.

Another study found that while patients who took dexamethasone might need to return to the doctor slightly more often, they were less likely to require hospital admission compared to those on other treatments. This resulted in fewer hospital stays after taking dexamethasone.

Overall, dexamethasone is considered safe, with side effects similar to other common treatments. This background demonstrates its safe use in various situations, but discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer new ways to manage asthma symptoms. Prednisone, a common oral steroid, requires a five-day course, while dexamethasone is delivered as a single intramuscular injection. This single-dose injection could mean fewer visits to the doctor and more convenience for patients. Additionally, both treatments aim to reduce inflammation quickly, but the method of delivery for dexamethasone provides a potential for faster relief with less hassle. These features may make managing asthma easier and more effective for many people.

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

This trial will compare two treatments for asthma: a single intramuscular steroid injection and an oral steroid short course. Research has shown that a single shot of dexamethasone, which participants in one arm of this trial may receive, works as well as taking prednisone pills for five days, which participants in another arm may receive, for treating mild to moderate asthma. Specifically, studies found that patients who received one dose of dexamethasone experienced similar outcomes to those who took prednisone for a longer period. Dexamethasone is also associated with fewer hospital visits, although this difference wasn't large enough to be conclusive. Overall, both treatments effectively manage asthma flare-ups, but dexamethasone offers the convenience of a one-time injection. ^{1 2 3 4 6}

Who Is on the Research Team?

Carlo Lutz, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with asthma who have had an exacerbation and visited the emergency department. It's not clear what specific exclusions are, but typically, people with certain other health issues or those taking conflicting medications might not qualify.

Inclusion Criteria

I have been diagnosed with asthma.

I was recently discharged from the emergency department with a worsening of my asthma.

I started taking corticosteroids during my emergency visit.

Exclusion Criteria

History of severe adverse reactions to corticosteroids

I am currently taking corticosteroids.

I have heart failure and my blood sugar was over 300 mg/dL when last checked.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a one-time IM dose of dexamethasone or a 5-day course of prednisone

5 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Prednisone

Trial Overview The study compares a single intramuscular (IM) shot of Dexamethasone (16mg) to a five-day oral course of Prednisone (60mg daily). The goal is to see if one dose of Dexamethasone can prevent return visits to the ED as effectively as the standard Prednisone treatment.

How Is the Trial Designed?

Group I: Oral Steroid Short Course Active Control 1 Intervention

Prednisone 60mg PO for 5 Days

Group II: Single Intramuscular Steroid Injection Active Control 1 Intervention

Dexamethasone 16mg Intramuscular Single Dose

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5640298/

Evaluation of the Efficacy of a Onetime Injectable ... This study showed that a single dose of oral dexamethasone (0.6 mg/kg) was non-inferior to a twice-daily, 5-day course of oral prednisone (2 mg/kg/day) in the ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022347600991066

A single dose of intramuscularly administered ... We found that a single IM injection of dexamethasone acetate was as effective as a 5-day course of PO Pred for the treatment of mild-moderate asthma ...

3. publications.aap.org publications.aap.org/pediatrics/article/156/1/e2024070153/202042/Adoption-of-Dexamethasone-for-Asthma-Exacerbations

Adoption of Dexamethasone for Asthma Exacerbations Dexamethasone was associated with a higher adjusted odds of return visit (1.07, 95% CI 1.03–1.11) and a lower adjusted odds of hospitalization ...

4. jpeds.com jpeds.com/article/S0022-3476(00)99106-6/abstract

A single dose of intramuscularly administered ... A single intramuscular injection of dexamethasone acetate was as effective as a 5-day course of PO Pred for the management of mild-moderate outpatient asthma ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475744/

Effects of Pre-Hospital Dexamethasone Administration on ... Dexamethasone-treated asthma patients had lower but statistically non-significant hospital admission rates (60.4% versus 78.0%, absolute difference: −17.55%, 95 ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ppul.26386

Dexamethasone versus methylprednisolone for critical ... Among children hospitalized for critical asthma, dexamethasone appears safe and warrants further investigation to fully assess clinical efficacy ...