Status AsthmaticusPhase 4IV:INTRAVENOUSNCT07731217
IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION
A Phase 4 study testing Intravenous Dexamethasone and Intravenous Methylprednisolone in people with Status Asthmaticus and Asthma (Diagnosis), run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Status Asthmaticus, Asthma (Diagnosis), Asthma Exacerbations
- What is being tested?
- Intravenous Dexamethasone and Intravenous Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of receiving salbutamol ± steroid treatment for two or more previous wheezing attacks, OR physician-diagnosed asthma.
- Patients admitted to the Pediatric Emergency Department due to severe asthma exacerbation (Pediatric Respiratory Assessment Measure [PRAM] score ≥8).
- -
- Exclusion Criteria: Patients with suspected or confirmed foreign body aspiration.
- Patients with concurrent croup.
- Presence of comorbidities (cardiovascular, neurological, malignancy, chronic kidney or lung disease).
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- Patients with pneumonia.
- Patients with air leaks (pneumothorax, pneumomediastinum).
- Patients requiring immediate Intensive Care Unit (ICU) admission.
- Systemic steroid use within the last 8 weeks.
- Failure to obtain informed consent.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: INTRAVENOUS DEXAMETHASONE VERSUS METHYLPREDNISOLONE IN WITH SEVERE ASTHMA EXACERBATION: A RANDOMISED, OPEN-LABEL, SINGLE-CENTRE STUDY
The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. To answer this question, researchers randomly assign eligible children to receive either IV dexamethasone or IV methylprednisolone. The clinical response to the treatments is objectively evaluated and compared using the Pediatric Respiratory Assessment Measure (PRAM) score at the 4th hour of treatment and on the 2nd day following hospital discharge.
- Conditions
- Status Asthmaticus, Asthma (Diagnosis), Asthma Exacerbations
- Being tested
- Intravenous Dexamethasone, Intravenous Methylprednisolone
- Keywords
- PRAM score, Severe Asthma Exacerbation, Acute Asthma, Dexamethasone, Methylprednisolone
- Medical subject headings
- Status Asthmaticus, Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous DexamethasoneDrug
Patients assigned to this intervention will receive intravenous dexamethasone at a dosage of 0.6 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum allowable dose is 16 mg/day, and the total duration of this treatment protocol is 2 days. If a patient is discharged from the hospital before the completion of the 2-day steroid protocol, the remaining treatment will be completed orally at home.
Intravenous MethylprednisoloneDrug
Patients assigned to this intervention will receive intravenous methylprednisolone at a dosage of 2 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum daily dose is age-dependent (30 mg/day for children aged 2-5 years; 60 mg/day for children aged 5-12 years; and 80 mg/day for children aged 12 years and older). The total duration of this standard treatment protocol is 5 days. If a patient is discharged from the hospital before the completion of the 5-day steroid protocol, the remaining treatment will be completed oral
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Dexamethasone | Experimental | Patients in this arm will receive intravenous dexamethasone at a dose of 0.6 mg/kg/day (maximum 16 mg/day), divided every 12 hours, for a total of 2 days. This is administered in addition to the standard emergency asthma exacerbation treatment. Receives: Drug: Intravenous Dexamethasone |
| Intravenous Methylprednisolone | Active comparator | Patients in this arm will receive intravenous methylprednisolone at a dose of 2 mg/kg/day (maximum doses: 30 mg/day for 2-5 years; 60 mg/day for 5-12 years; 80 mg/day for ≥12 years), divided every 12 hours, for a total of 5 days. This is administered in addition to the standard emergency asthma exacerbation treatment. Receives: Drug: Intravenous Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour
The PRAM score is a validated clinical scoring system used to assess asthma severity in children. It evaluates clinical signs including suprasternal retractions, scalene muscle contraction, air entry, wheezing, and O2 saturation. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
Measured: At 4 hours after the initiation of treatment in the emergency department.
PRAM Score on the 2nd Day Post-Discharge
The PRAM score will be calculated to assess the patient's respiratory status during the follow-up visit. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
Measured: 2 days after discharge from the hospital
Secondary outcomes (6)
Total Number of Salbutamol Doses
The total number of short-acting beta-agonist (salbutamol) doses required by the patient after discharge.
Measured: Up to 14 days post-discharge.
Hospitalization Rate
The percentage of patients who require admission to the pediatric allergy ward or intensive care unit due to inadequate response to emergency treatment.
Measured: Up to 4 hours post-treatment initiation in the emergency department.
Length of Hospital Stay
The total duration the patient remains in the hospital (emergency department, ward, or ICU) from admission to discharge.
Measured: From hospital admission to hospital discharge (an expected average of 2 to 5 days)
Rate of Re-presentation to the Hospital
The percentage of patients who return to the emergency department or outpatient clinic with a new or worsened asthma exacerbation.
Measured: Within 14 days post-discharge
Re-hospitalization Rate
The percentage of patients who require a new hospital admission due to asthma exacerbation after their initial discharge.
Measured: Within 14 days post-discharge
Incidence of Adverse Events
The number of participants experiencing corticosteroid-related adverse events, including vomiting, hyperglycemia, gastrointestinal bleeding, and hypertension.
Measured: Up to 14 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Sep 2025
- Primary completion1 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status AsthmaticusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esen Besli, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731217
- Sponsor's protocol ID
- 2025/0050
- Acronym
- IV:INTRAVENOUS
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRAVENOUS DEXAMETHASONE VERSUS METHYLPREDNISOLONE IN WITH SEVERE ASTHMA EXACERBATION: A RANDOMISED, OPEN-LABEL, SINGLE-CENTRE STUDY
- ClinicalTrials.gov ID
- NCT07731217
- Acronym / sponsor ID
- IV:INTRAVENOUS / 2025/0050
- Conditions
- Status Asthmaticus, Asthma (Diagnosis), Asthma Exacerbations
- Keywords
- PRAM score, Severe Asthma Exacerbation, Acute Asthma, Dexamethasone, Methylprednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 28 Jul 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.
The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. To answer this question, researchers randomly assign eligible children to receive either IV dexamethasone or IV methylprednisolone. The clinical response to the treatments is objectively evaluated and compared using the Pediatric Respiratory Assessment Measure (PRAM) score at the 4th hour of treatment and on the 2nd day following hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Dexamethasone | Experimental | Drug: Intravenous DexamethasonePatients in this arm will receive intravenous dexamethasone at a dose of 0.6 mg/kg/day (maximum 16 mg/day), divided every 12 hours, for a total of 2 days. This is administered in addition to the standard emergency asthma exacerbation treatment. |
| Intravenous Methylprednisolone | Active comparator | Drug: Intravenous MethylprednisolonePatients in this arm will receive intravenous methylprednisolone at a dose of 2 mg/kg/day (maximum doses: 30 mg/day for 2-5 years; 60 mg/day for 5-12 years; 80 mg/day for ≥12 years), divided every 12 hours, for a total of 5 days. This is administered in addition to the standard emergency asthma exacerbation treatment. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- History of receiving salbutamol ± steroid treatment for two or more previous wheezing attacks, OR physician-diagnosed asthma.
- Patients admitted to the Pediatric Emergency Department due to severe asthma exacerbation (Pediatric Respiratory Assessment Measure [PRAM] score ≥8).
- -
- Exclusion Criteria: Patients with suspected or confirmed foreign body aspiration.
- Patients with concurrent croup.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intravenous DexamethasonePatients assigned to this intervention will receive intravenous dexamethasone at a dosage of 0.6 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum allowable dose is 16 mg/day, and the total duration of this treatment protocol is 2 days. If a patient is discharged from the hospital before the completion of the 2-day steroid protocol, the remaining treatment will be completed orally at home. | Drug | Intravenous Dexamethasone |
| Intravenous MethylprednisolonePatients assigned to this intervention will receive intravenous methylprednisolone at a dosage of 2 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum daily dose is age-dependent (30 mg/day for children aged 2-5 years; 60 mg/day for children aged 5-12 years; and 80 mg/day for children aged 12 years and older). The total duration of this standard treatment protocol is 5 days. If a patient is discharged from the hospital before the completion of the 5-day steroid protocol, the remaining treatment will be completed oral | Drug | Intravenous Methylprednisolone |
Primary outcome
PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour
Time frame: At 4 hours after the initiation of treatment in the emergency department.
The PRAM score is a validated clinical scoring system used to assess asthma severity in children. It evaluates clinical signs including suprasternal retractions, scalene muscle contraction, air entry, wheezing, and O2 saturation. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
PRAM Score on the 2nd Day Post-Discharge
Time frame: 2 days after discharge from the hospital
The PRAM score will be calculated to assess the patient's respiratory status during the follow-up visit. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.
6 secondary outcomes
Total Number of Salbutamol Doses
Time frame: Up to 14 days post-discharge.
Hospitalization Rate
Time frame: Up to 4 hours post-treatment initiation in the emergency department.
Length of Hospital Stay
Time frame: From hospital admission to hospital discharge (an expected average of 2 to 5 days)
Rate of Re-presentation to the Hospital
Time frame: Within 14 days post-discharge
Re-hospitalization Rate
Time frame: Within 14 days post-discharge
Incidence of Adverse Events
Time frame: Up to 14 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Intravenous Dexamethasone and Intravenous Methylprednisolone in people with Status Asthmaticus and Asthma (Diagnosis), run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 12 inclusion and 0 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: finished, as of the sponsor's last update on 28 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour (time frame: At 4 hours after the initiation of treatment in the emergency department.). 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?
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 28 Jul 2026.