NCT07228052 Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department
| NCT ID | NCT07228052 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Montefiore Medical Center |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2026-07-23 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 182 participants in total. It began in 2026-07-23 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations. This is a randomized, controlled, double-blind, non-inferiority trial conducted at two urban EDs within the Montefiore Health System.
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 years old presenting to the ED with an asthma exacerbation * Diagnosed with asthma per International Classification of Diseases, 10th Revision (ICD-10) criteria or by the treating clinician * Discharged from the ED with a primary diagnosis of asthma exacerbation * Initiated systemic corticosteroids during the ED visit * Must be English or Spanish speaking Exclusion Criteria: * Current use of systemic corticosteroids, including Emergency Medical Services (EMS) administration before ED arrival * History of severe adverse reactions to corticosteroids * Heart failure and uncontrolled diabetes (glucose \>300mg/dL in the ED) * Pregnancy or breastfeeding as prednisone is the preferred treatment for asthma in this population * Inability to provide informed consent
Contact & Investigator
Carlo Lutz, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT07228052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07228052 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07228052 currently recruiting?
Yes, NCT07228052 is actively recruiting participants. Contact the research team at mmanzur@montefiore.org for enrollment information.
Where is the NCT07228052 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07228052 clinical trial?
NCT07228052 is sponsored by Montefiore Medical Center. The principal investigator is Carlo Lutz, MD at Montefiore Medical Center. The trial plans to enroll 182 participants.
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