Asthma (Diagnosis)Phase 2PATCHNCT07455396
Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
A Phase 2 study testing Dexamethasone (0.6mg/kg; Max 16mg) Once Daily, Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours and Methylprednisolone in people with Asthma (Diagnosis), run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous systemic corticosteroids (SCs), but there remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Dexamethasone (0.6mg/kg; Max 16mg) Once Daily, Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 14 Aug 2028
- Phase
- Phase 2
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-17 years
- Intensive care unit admission
- Treatment for critical asthma
Who cannot join
- History of unrepaired critical congenital heart disease
- History of cystic fibrosis
- Active tracheostomy dependence
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
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Meghan Sorondo, PharmD, 727-767-7044, mroddy4@jhmi.edu
Anthony Sochet, MD, MSc, 7277672912, sochet@jh.edu
About this study
Official title: Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): A Phase 2 Prospective Randomized Open Blinded End-point (PROBE) Design, Randomized Clinical Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous systemic corticosteroids (SCs), but there remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. Regimens are often chosen based on provider preference, and different strategies include once-daily dosing (ODD) dexamethasone (DM) 0.6 mg/kg/dose for 2 days, every 6 hours (q6h) DM 0.25 mg/kg/dose for 2 days, and methylprednisolone (MP) 1 mg/kg/dose every 6 hours for 5-days.
To address this knowledge gap, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for critical asthma (CA) randomized to one of three regimens above. The study would be powered to evaluate rates of additional prescriptions of SC and also secondarily evaluate quality of life metrics.
Read the detailed description
Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous SCs.17 These agents placate the inflammatory process mediated by airway and systemic leukocytes and have been shown to improve the efficacy of nebulized bronchodilators (i.e., β-2 agonists).18-23 There remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. While the benefits of SCs for asthma exacerbation have been demonstrated in observational data and rare early phase trials, only one prospective trial conducted by the investigators group 6 has specifically compared IV SCs in the Pediatric Intensive Care Unit (PICU) setting among children hospitalized with CA.1 As a result, specific IV SCs for CA are chosen at the discretion of clinical providers with wide variety observed including ODD DM at 0.6mg/kg/dose for 2 days, q6h DM at 0.25 mg/kg/dose for 2 days, and MP 1mg/kg/dose every 6 hours for 5-days24.
In the investigators early phase clinical trial for SCs for pediatric CA, the investigators compared q6H DM to MP and detected no difference in SC-related adverse events of special interest (AESI), continuous β-2-agonist exposure, and hospital LOS.6 Routine endpoints (i.e., mortality, invasive mechanical ventilation (IMV), and LOS) exhibit limited variability and are rare in cases of pediatric CA. As such, more pragmatic clinical endpoints have been proposed by the investigators research group and others including same cause rehospitalization rates, additional post-discharge SC exposure rate, and markers of QOL including the number of missed school days / sports, and a validated QOL scale (i.e., mini-Pediatric Asthma Quality of Life Questionnaire (PAQLQ12-16). For children discharged from Johns Hopkins All Children's with CA, the investigators estimate rehospitalization rates for CA with receipt of subsequent SCs ≤ 30 days of discharge are between 18-45%, with lower rates observed for MP over DM.
To rigorously address these knowledge gaps, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for CA randomized to IV DM (stratified further by q6h and ODD dosing regimens) or IV MP powered to evaluate pragmatic post-discharge endpoints including the rate of additional SC exposure ≤ 30-days of hospital discharge and QOL measures at 30-days after hospital discharge measured by the mini-PAQLQ, the number of missed school days, and number of missed days of play and sports. The investigators will additionally characterize and compare safety (i.e., SC-related AESI and serious adverse events (SAEs) and acute inpatient clinical efficacy (i.e., CA-adjunct intervention free hours) endpoints by randomized SC arms.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Dexamethasone (0.6mg/kg; Max 16mg) Once Daily, Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours, Methylprednisolone
- Keywords
- pediatric critical asthma, pediatric intensive care unit, status asthmaticus, systemic corticosteroids, methylprednisolone, dexamethasone
- Medical subject headings
- Asthma, Disease, Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (0.6mg/kg; Max 16mg) Once DailyDrug
For this intervention, Dexamethasone will be administered at 0.6mg/kg/dose once daily for a maximum dose of 16 mg for 2 days
Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hoursDrug
For this intervention, Dexamethasone will be administered at 0.25mg/kg/dose every 6 hours for a maximum dose of 16 mg for 2 days
For this intervention, Methylprednisolone will be administered at 1 mg/kg/dose every 6 hours for a maximum dose of 60 mg for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Once Daily Dosing for 2days | Active comparator | Dexamethasone Intravenous 0.6mg/kg/dose once daily for two days (Max Dose: 16mg) Receives: Drug: Dexamethasone (0.6mg/kg; Max 16mg) Once Daily |
| Dexamethasone Every 6-Hours Dosing for 2 days | Active comparator | Dexamethasone 0.25mg/kg/dose every 6-hours for 8-total doses (i.e., 2 days) Max Dose 16mg per administration Receives: Drug: Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours |
| Methylprednisolone Every 6-hours Dosing for 5-days | Active comparator | Methylprednisolone 1mg/kg every 6-hours for 5-days Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Discharge Systemic Corticosteroid Exposure
Aggregate occurrence rate (i.e., risk) of systemic corticosteroid exposures after hospital discharge
Measured: Within 30 days of hospital discharge
Cumulative Adverse Events of Special Interest
Cumulative Adverse Events of Special Interest are inclusive of symptomatic hypertension requiring an antihypertensive agent, symptomatic hyperglycemia requiring insulin, symptomatic agitation requiring antipsychotic agent or sedative administration, adrenal insufficiency, and candidiasis.
Measured: From enrollment through 30-days following hospital discharge
Secondary outcomes (2)
Pediatric Asthma Quality of Life
Pediatric Asthma Quality of Life Questionnaire. Mean scores range from 1 to 7. Higher score indicating higher quality of life.
Measured: Measured at 30-days post hospital discharge
Critical Asthma Adjunct Intervention Free Hours
Critical Asthma Adjunct Intervention Free Hours includes the cumulative number of hours during hospitalization where no critical asthma adjunct interventions are administered.
Measured: From Enrollment through 30 days post Hospital Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Aug 2026
- Primary completion14 Aug 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PROBE design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan Sorondo, PharmD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455396
- Sponsor's protocol ID
- IRB00544439
- Acronym
- PATCH
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sellers AR, Roddy MR, Darville KK, Sanchez-Teppa B, McKinley SD, Sochet AA. Dexamethasone for Pediatric Critical Asthma: A Multicenter Descriptive Study. J Intensive Care Med. 2022 Nov;37(11):1520-1527. doi: 10.1177/08850666221082540. Epub 2022 Mar 3.
PubMed 35236174Roddy MR, Sellers AR, Darville KK, Teppa-Sanchez B, McKinley SD, Martin M, Goldenberg NA, Nakagawa TA, Sochet AA. Dexamethasone versus methylprednisolone for critical asthma: A single center, open-label, parallel-group clinical trial. Pediatr Pulmonol. 2023 Jun;58(6):1719-1727. doi: 10.1002/ppul.26386. Epub 2023 Mar 17.
PubMed 36929864Fowler CA, Ryder JM, Roberts AR, Sochet AA, Roddy MR. Methylprednisolone dosing for pediatric critical asthma: a single-center cohort study. J Asthma. 2024 Dec;61(12):1672-1678. doi: 10.1080/02770903.2024.2375276. Epub 2024 Jul 6.
PubMed 38954523
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): A Phase 2 Prospective Randomized Open Blinded End-point (PROBE) Design, Randomized Clinical Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
- ClinicalTrials.gov ID
- NCT07455396
- Acronym / sponsor ID
- PATCH / IRB00544439
- Conditions
- Asthma (Diagnosis)
- Keywords
- pediatric critical asthma, pediatric intensive care unit, status asthmaticus, systemic corticosteroids, methylprednisolone, dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 14 Aug 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous systemic corticosteroids (SCs), but there remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. Regimens are often chosen based on provider preference, and different strategies include once-daily dosing (ODD) dexamethasone (DM) 0.6 mg/kg/dose for 2 days, every 6 hours (q6h) DM 0.25 mg/kg/dose for 2 days, and methylprednisolone (MP) 1 mg/kg/dose every 6 hours for 5-days.
To address this knowledge gap, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for critical asthma (CA) randomized to one of three regimens above. The study would be powered to evaluate rates of additional prescriptions of SC and also secondarily evaluate quality of life metrics.
Detailed description
Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous SCs.17 These agents placate the inflammatory process mediated by airway and systemic leukocytes and have been shown to improve the efficacy of nebulized bronchodilators (i.e., β-2 agonists).18-23 There remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. While the benefits of SCs for asthma exacerbation have been demonstrated in observational data and rare early phase trials, only one prospective trial conducted by the investigators group 6 has specifically compared IV SCs in the Pediatric Intensive Care Unit (PICU) setting among children hospitalized with CA.1 As a result, specific IV SCs for CA are chosen at the discretion of clinical providers with wide variety observed including ODD DM at 0.6mg/kg/dose for 2 days, q6h DM at 0.25 mg/kg/dose for 2 days, and MP 1mg/kg/dose every 6 hours for 5-days24.
In the investigators early phase clinical trial for SCs for pediatric CA, the investigators compared q6H DM to MP and detected no difference in SC-related adverse events of special interest (AESI), continuous β-2-agonist exposure, and hospital LOS.6 Routine endpoints (i.e., mortality, invasive mechanical ventilation (IMV), and LOS) exhibit limited variability and are rare in cases of pediatric CA. As such, more pragmatic clinical endpoints have been proposed by the investigators research group and others including same cause rehospitalization rates, additional post-discharge SC exposure rate, and markers of QOL including the number of missed school days / sports, and a validated QOL scale (i.e., mini-Pediatric Asthma Quality of Life Questionnaire (PAQLQ12-16). For children discharged from Johns Hopkins All Children's with CA, the investigators estimate rehospitalization rates for CA with receipt of subsequent SCs ≤ 30 days of discharge are between 18-45%, with lower rates observed for MP over DM.
To rigorously address these knowledge gaps, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for CA randomized to IV DM (stratified further by q6h and ODD dosing regimens) or IV MP powered to evaluate pragmatic post-discharge endpoints including the rate of additional SC exposure ≤ 30-days of hospital discharge and QOL measures at 30-days after hospital discharge measured by the mini-PAQLQ, the number of missed school days, and number of missed days of play and sports. The investigators will additionally characterize and compare safety (i.e., SC-related AESI and serious adverse events (SAEs) and acute inpatient clinical efficacy (i.e., CA-adjunct intervention free hours) endpoints by randomized SC arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- PROBE design
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Once Daily Dosing for 2days | Active comparator | Drug: Dexamethasone (0.6mg/kg; Max 16mg) Once DailyDexamethasone Intravenous 0.6mg/kg/dose once daily for two days (Max Dose: 16mg) |
| Dexamethasone Every 6-Hours Dosing for 2 days | Active comparator | Drug: Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hoursDexamethasone 0.25mg/kg/dose every 6-hours for 8-total doses (i.e., 2 days) Max Dose 16mg per administration |
| Methylprednisolone Every 6-hours Dosing for 5-days | Active comparator | Drug: MethylprednisoloneMethylprednisolone 1mg/kg every 6-hours for 5-days |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 3-17 years
- Intensive care unit admission
- Treatment for critical asthma
Key exclusion criteria (3 listed)
- History of unrepaired critical congenital heart disease
- History of cystic fibrosis
- Active tracheostomy dependence
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 (0.6mg/kg; Max 16mg) Once DailyFor this intervention, Dexamethasone will be administered at 0.6mg/kg/dose once daily for a maximum dose of 16 mg for 2 days | Drug | Dexamethasone Once Daily Dosing for 2days |
| Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hoursFor this intervention, Dexamethasone will be administered at 0.25mg/kg/dose every 6 hours for a maximum dose of 16 mg for 2 days | Drug | Dexamethasone Every 6-Hours Dosing for 2 days |
| MethylprednisoloneFor this intervention, Methylprednisolone will be administered at 1 mg/kg/dose every 6 hours for a maximum dose of 60 mg for 5 days | Drug | Methylprednisolone Every 6-hours Dosing for 5-days |
Primary outcome
Post-Discharge Systemic Corticosteroid Exposure
Time frame: Within 30 days of hospital discharge
Aggregate occurrence rate (i.e., risk) of systemic corticosteroid exposures after hospital discharge
Cumulative Adverse Events of Special Interest
Time frame: From enrollment through 30-days following hospital discharge
Cumulative Adverse Events of Special Interest are inclusive of symptomatic hypertension requiring an antihypertensive agent, symptomatic hyperglycemia requiring insulin, symptomatic agitation requiring antipsychotic agent or sedative administration, adrenal insufficiency, and candidiasis.
2 secondary outcomes
Pediatric Asthma Quality of Life
Time frame: Measured at 30-days post hospital discharge
Critical Asthma Adjunct Intervention Free Hours
Time frame: From Enrollment through 30 days post Hospital Discharge
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 12 Aug 2026.
- Background: PubMed 35236174Sellers AR, Roddy MR, Darville KK, Sanchez-Teppa B, McKinley SD, Sochet AA. Dexamethasone for Pediatric Critical Asthma: A Multicenter Descriptive Study. J Intensive Care Med. 2022 Nov;37(11):1520-1527. doi: 10.1177/08850666221082540. Epub 2022 Mar 3.
- Background: PubMed 36929864Roddy MR, Sellers AR, Darville KK, Teppa-Sanchez B, McKinley SD, Martin M, Goldenberg NA, Nakagawa TA, Sochet AA. Dexamethasone versus methylprednisolone for critical asthma: A single center, open-label, parallel-group clinical trial. Pediatr Pulmonol. 2023 Jun;58(6):1719-1727. doi: 10.1002/ppul.26386. Epub 2023 Mar 17.
- Background: PubMed 38954523Fowler CA, Ryder JM, Roberts AR, Sochet AA, Roddy MR. Methylprednisolone dosing for pediatric critical asthma: a single-center cohort study. J Asthma. 2024 Dec;61(12):1672-1678. doi: 10.1080/02770903.2024.2375276. Epub 2024 Jul 6.
- Individual participant dataSharing planned: No
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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.
Meghan Sorondo, PharmD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone (0.6mg/kg; Max 16mg) Once Daily, Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours and Methylprednisolone in people with Asthma (Diagnosis), run by Johns Hopkins All Children's Hospital 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 3 inclusion and 3 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 12 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Meghan Sorondo, PharmD (727-767-7044, mroddy4@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Discharge Systemic Corticosteroid Exposure (time frame: Within 30 days of hospital discharge). The study lists 2 primary outcomes in all. 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 NCT07455396, which also lists 3 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 12 Aug 2026.