AsthmaPhase 4GASPINGNCT07228052
Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department
A Phase 4 study testing Dexamethasone 16mg IM and Prednisone 60mg PO in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Dexamethasone 16mg IM and Prednisone 60mg PO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Mustfa Manzur, MD MPH MS, 718-920-6626, mmanzur@montefiore.org
About this study
Official title: Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department: A Randomized Control Trial
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.
Read the detailed description
Asthma exacerbations are a leading cause of emergency department (ED) visits in the United States. In pediatric patients, a single dose of dexamethasone has been widely adopted as an effective and convenient alternative to multi-day oral steroid regimens. However, in adults, evidence regarding the efficacy of a single-dose steroid approach compared to a traditional 5-day course of oral prednisone is mixed. Despite the availability of oral corticosteroids like prednisone, medication adherence after ED discharge remains a significant challenge. Studies indicate that only about 30% of ED patients fill prescribed medications post-discharge. A single-dose intramuscular (IM) dexamethasone regimen offers the advantage of ensuring adequate anti-inflammatory effects for asthma exacerbations. 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.
- Conditions
- Asthma
- Being tested
- Dexamethasone 16mg IM, Prednisone 60mg PO
- Keywords
- dexamethasone, prednisone, randomized controlled trial
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 16mg IMDrug
Dexamethasone 16mg Intramuscular Administration Once
Prednisone 60mg PODrug
Prednisone 60mg PO for 5 Days
| Study group | Role | What they receive |
|---|---|---|
| Single Intramuscular Steroid Injection | Active comparator | Dexamethasone 16mg Intramuscular Single Dose Receives: Drug: Dexamethasone 16mg IM |
| Oral Steroid Short Course | Active comparator | Prednisone 60mg PO for 5 Days Receives: Drug: Prednisone 60mg PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test Score
Asthma control will be assessed via administration of the Asthma Control Test (ACT) questionnaire at 4 weeks post-discharge. The ACT questionnaire is comprised of 5 questions which ask participants to recall how asthma symptoms have affected them over the prior 4 weeks. Responses to the 5 questions are rated on a 5-point Likert scale ranging from 1-5, yielding an overall possible scoring range of 5-25. Higher ACT scores are indicative of better asthma control. For this study, an ACT score >19 indicates well-controlled asthma. Scores will be summarized by study arm using basic descriptive statistics.
Measured: Within 4 Weeks post-discharge, up to 28-30 days
Secondary outcomes (3)
ED or Hospitalization for Asthma
The number of return visits to the ED or hospitalizations related to asthma, within 30 days post-discharge, will be summarized by study arm using basic descriptive statistics.
Measured: Within 4 Weeks post-discharge, up to 28-30 days
Change in Quality of Life
Change in Quality of Life will be measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ). The MiniAQLQ is a 21-item survey which consists of questions spanning four domains: symptoms, activity limitations, emotional function, and environmental stimuli, in order to understand how asthma affects patients in daily life. Responses to the first 15 questions are rated on a 7-point scale ranging from 1-7, questions 16-20 are rated using a 3-point scale ranging from 1-3, and question 21 is rated on 0-10 scale, with higher scores being indicative of a better quality of life, yielding an overall possible scoring range of 20-130. Scores will be summarized by study arm.
Measured: At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days
Adverse Effects
Documented occurrence of Adverse Effects, including nausea, headache, rash, or Serious Adverse Events, as defined by International Conference on Harmonisation - Good Clinical Practice (ICH GCP) guidelines, will be summarized by study arm.
Measured: At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start23 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned 1:1 to a treatment group using a computer-generated randomization schedule.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Lutz, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228052
- Sponsor's protocol ID
- 2025-16648
- Other IDs
- 2025
- Acronym
- GASPING
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Hasegawa K, Craig SS, Teach SJ, Camargo CA Jr. Management of Asthma Exacerbations in the Emergency Department. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2599-2610. doi: 10.1016/j.jaip.2020.12.037. Epub 2020 Dec 31.
PubMed 33387672Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.
PubMed 24515516Kirkland SW, Cross E, Campbell S, Villa-Roel C, Rowe BH. Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma. Cochrane Database Syst Rev. 2018 Jun 2;6(6):CD012629. doi: 10.1002/14651858.CD012629.pub2.
PubMed 29859017Fischer MA, Jones JB, Wright E, Van Loan RP, Xie J, Gallagher L, Wurst AM, Shrank WH. A randomized telephone intervention trial to reduce primary medication nonadherence. J Manag Care Spec Pharm. 2015 Feb;21(2):124-31. doi: 10.18553/jmcp.2015.21.2.124.
PubMed 25615001Gordon S, Tompkins T, Dayan PS. Randomized trial of single-dose intramuscular dexamethasone compared with prednisolone for children with acute asthma. Pediatr Emerg Care. 2007 Aug;23(8):521-7. doi: 10.1097/PEC.0b013e318128f821.
PubMed 17726409Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.
PubMed 11445789Nelsen LM, Kosinski M, Rizio AA, Jacques L, Schatz M, Stanford RH, Svedsater H. A structured review evaluating content validity of the Asthma Control Test, and its consistency with U.S. guidelines and patient expectations for asthma control. J Asthma. 2022 Mar;59(3):628-637. doi: 10.1080/02770903.2020.1861624. Epub 2020 Dec 30.
PubMed 33377411Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.
PubMed 10489826Alzahrani YA, Becker EA. Asthma Control Assessment Tools. Respir Care. 2016 Jan;61(1):106-16. doi: 10.4187/respcare.04341. Epub 2015 Nov 10.
PubMed 26556901Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.
PubMed 19767070
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07228052
- Acronym / sponsor ID
- GASPING / 2025-16648
- Conditions
- Asthma
- Keywords
- dexamethasone, prednisone, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma exacerbations are a leading cause of emergency department (ED) visits in the United States. In pediatric patients, a single dose of dexamethasone has been widely adopted as an effective and convenient alternative to multi-day oral steroid regimens. However, in adults, evidence regarding the efficacy of a single-dose steroid approach compared to a traditional 5-day course of oral prednisone is mixed. Despite the availability of oral corticosteroids like prednisone, medication adherence after ED discharge remains a significant challenge. Studies indicate that only about 30% of ED patients fill prescribed medications post-discharge. A single-dose intramuscular (IM) dexamethasone regimen offers the advantage of ensuring adequate anti-inflammatory effects for asthma exacerbations. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned 1:1 to a treatment group using a computer-generated randomization schedule.
| Arm | Type | Receives |
|---|---|---|
| Single Intramuscular Steroid Injection | Active comparator | Drug: Dexamethasone 16mg IMDexamethasone 16mg Intramuscular Single Dose |
| Oral Steroid Short Course | Active comparator | Drug: Prednisone 60mg POPrednisone 60mg PO for 5 Days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 16mg IMDexamethasone 16mg Intramuscular Administration Once | Drug | Single Intramuscular Steroid Injection |
| Prednisone 60mg POPrednisone 60mg PO for 5 Days | Drug | Oral Steroid Short Course |
Primary outcome
Asthma Control Test Score
Time frame: Within 4 Weeks post-discharge, up to 28-30 days
Asthma control will be assessed via administration of the Asthma Control Test (ACT) questionnaire at 4 weeks post-discharge. The ACT questionnaire is comprised of 5 questions which ask participants to recall how asthma symptoms have affected them over the prior 4 weeks. Responses to the 5 questions are rated on a 5-point Likert scale ranging from 1-5, yielding an overall possible scoring range of 5-25. Higher ACT scores are indicative of better asthma control. For this study, an ACT score >19 indicates well-controlled asthma. Scores will be summarized by study arm using basic descriptive statistics.
3 secondary outcomes
ED or Hospitalization for Asthma
Time frame: Within 4 Weeks post-discharge, up to 28-30 days
Change in Quality of Life
Time frame: At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days
Adverse Effects
Time frame: At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 33387672Hasegawa K, Craig SS, Teach SJ, Camargo CA Jr. Management of Asthma Exacerbations in the Emergency Department. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2599-2610. doi: 10.1016/j.jaip.2020.12.037. Epub 2020 Dec 31.
- Background: PubMed 24515516Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.
- Background: PubMed 29859017Kirkland SW, Cross E, Campbell S, Villa-Roel C, Rowe BH. Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma. Cochrane Database Syst Rev. 2018 Jun 2;6(6):CD012629. doi: 10.1002/14651858.CD012629.pub2.
- Background: PubMed 25615001Fischer MA, Jones JB, Wright E, Van Loan RP, Xie J, Gallagher L, Wurst AM, Shrank WH. A randomized telephone intervention trial to reduce primary medication nonadherence. J Manag Care Spec Pharm. 2015 Feb;21(2):124-31. doi: 10.18553/jmcp.2015.21.2.124.
- Background: PubMed 17726409Gordon S, Tompkins T, Dayan PS. Randomized trial of single-dose intramuscular dexamethasone compared with prednisolone for children with acute asthma. Pediatr Emerg Care. 2007 Aug;23(8):521-7. doi: 10.1097/PEC.0b013e318128f821.
- Background: PubMed 11445789Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.
- Background: PubMed 33377411Nelsen LM, Kosinski M, Rizio AA, Jacques L, Schatz M, Stanford RH, Svedsater H. A structured review evaluating content validity of the Asthma Control Test, and its consistency with U.S. guidelines and patient expectations for asthma control. J Asthma. 2022 Mar;59(3):628-637. doi: 10.1080/02770903.2020.1861624. Epub 2020 Dec 30.
- Background: PubMed 10489826Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.
- Background: PubMed 26556901Alzahrani YA, Becker EA. Asthma Control Assessment Tools. Respir Care. 2016 Jan;61(1):106-16. doi: 10.4187/respcare.04341. Epub 2015 Nov 10.
- Background: PubMed 19767070Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo Lutz, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone 16mg IM and Prednisone 60mg PO in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustfa Manzur, MD MPH MS (718-920-6626, mmanzur@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test Score (time frame: Within 4 Weeks post-discharge, up to 28-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07228052, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.