Acute Exacerbation of AsthmaNCT07275593
Dexamethasone Versus Prednisolone in Acute Exacerbation of Childhood Asthma
A study testing Dexamethasone and Prednisolone in people with Acute Exacerbation of Asthma, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Because of insufficient local comparative data, this study was designed to determine the outcome of intravenous dexamethasone in contrast to oral prednisolone in acute exacerbation of asthmatic children. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Acute Exacerbation of Asthma
- What is being tested?
- Dexamethasone and Prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Nov 2024to 3 Apr 2025
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of any gender
- Aged 2-12 years
- Presenting with acute exacerbation of asthma within 24-hours
Who cannot join
- Children with PRAM score of ≥ 10
- Used oral or parenteral corticosteroids in last 4-weeks
- With any chronic condition of lungs (TB, cystic fibrosis), liver (chronic liver disease), kidneys (chronic kidney disease, nephrotic syndrome) or blood (thalassemia, malignancy)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nishtar Medical University Hospital
Multan, Punjab Province, 66000
About this study
Official title: Comparison of Outcome Between Dexamethasone Versus Prednisolone Administration in Acute Exacerbation of Childhood Asthma
Because of insufficient local comparative data, this study was designed to determine the outcome of intravenous dexamethasone in contrast to oral prednisolone in acute exacerbation of asthmatic children.
Read the detailed description
The findings of this study would furnish the local data. The results would also provide recommendations to use more appropriate steroid options in the local settings, resulting in aid to improve the quality of life of asthmatic children and their quicker return to daily routine activities.
- Conditions
- Acute Exacerbation of Asthma
- Being tested
- Dexamethasone, Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients received single IV dose of Dexamethasone at a dose of 0.6 mg/kg
PrednisoloneDrug
Patients received oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Dexamethasone Group | Experimental | Patients received a single IV dose of dexamethasone at a dose of 0.6 mg/kg. Receives: Drug: Dexamethasone |
| Oral Prednisone Group | Experimental | Patients were given oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbation
The Pediatric Respiratory Assessment Measure (PRAM) score was used to assess the severity of asthma exacerbation. This score consisted of 5 items and had a maximum score of 12: suprasternal retractions (0-2), scalene muscle contraction (0-2), air entry in chest (0-3), wheeze (0-3), and oxygen saturation (0-2). A score of 1-3 showed mild exacerbation, 4-7 showed moderate exacerbation, and 8-12 revealed severe exacerbation of asthma.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start3 Nov 2024
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of AsthmaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Asif Abrar, Principal investigator, Nishter Hospital Multan, PakistanAzam Khan, Study director, Nishter Hospital Multan, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275593
- Sponsor's protocol ID
- DR-ASIF-MULTAN
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome Between Dexamethasone Versus Prednisolone Administration in Acute Exacerbation of Childhood Asthma
- ClinicalTrials.gov ID
- NCT07275593
- Acronym / sponsor ID
- DR-ASIF-MULTAN
- Conditions
- Acute Exacerbation of Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 10 Dec 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.
Because of insufficient local comparative data, this study was designed to determine the outcome of intravenous dexamethasone in contrast to oral prednisolone in acute exacerbation of asthmatic children.
Detailed description
The findings of this study would furnish the local data. The results would also provide recommendations to use more appropriate steroid options in the local settings, resulting in aid to improve the quality of life of asthmatic children and their quicker return to daily routine activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Dexamethasone Group | Experimental | Drug: DexamethasonePatients received a single IV dose of dexamethasone at a dose of 0.6 mg/kg. |
| Oral Prednisone Group | Experimental | Drug: PrednisolonePatients were given oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of any gender
- Aged 2-12 years
- Presenting with acute exacerbation of asthma within 24-hours
Key exclusion criteria (3 listed)
- Children with PRAM score of ≥ 10
- Used oral or parenteral corticosteroids in last 4-weeks
- With any chronic condition of lungs (TB, cystic fibrosis), liver (chronic liver disease), kidneys (chronic kidney disease, nephrotic syndrome) or blood (thalassemia, malignancy)
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 |
|---|---|---|
| DexamethasonePatients received single IV dose of Dexamethasone at a dose of 0.6 mg/kg | Drug | Intravenous Dexamethasone Group |
| PrednisolonePatients received oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days. | Drug | Oral Prednisone Group |
Primary outcome
Asthma exacerbation
Time frame: 4 days
The Pediatric Respiratory Assessment Measure (PRAM) score was used to assess the severity of asthma exacerbation. This score consisted of 5 items and had a maximum score of 12: suprasternal retractions (0-2), scalene muscle contraction (0-2), air entry in chest (0-3), wheeze (0-3), and oxygen saturation (0-2). A score of 1-3 showed mild exacerbation, 4-7 showed moderate exacerbation, and 8-12 revealed severe exacerbation of asthma.
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 10 Dec 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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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.
Asif Abrar principal investigator
Nishter Hospital Multan, Pakistan
Azam Khan study director
Nishter Hospital Multan, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Prednisolone in people with Acute Exacerbation of Asthma, run by Muhammad Aamir Latif at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 10 Dec 2025. 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 Pakistan. 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.
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?
Asthma exacerbation (time frame: 4 days). 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 10 Dec 2025.