| CTRI Number |
CTRI/2025/09/094899 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing effectiveness of dexamethasone with prednisolone in children with acute exacerbation of asthma |
|
Scientific Title of Study
|
Comparative efficacy of oral dexamethasone
with prednisolone in children with acute
exacerbation of asthma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pryas Jain |
| Designation |
Junior resident, Paediatrics |
| Affiliation |
Government medical college, Chandigarh |
| Address |
Dept. Of Paediatrics, 4th floor, B block, GMCH, sector 32, 160030, Chandigarh,
Dept. Of Paediatrics, 4th floor, B block, GMCH, sector 32, 160030, Chandigarh,
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9988651512 |
| Fax |
|
| Email |
pryj2609@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pankaj Kumar |
| Designation |
Assistant professor, Paediatrics |
| Affiliation |
Government medical college, Chandigarh |
| Address |
Dept. Of Paediatrics, 4th floor, B block, GMCH, sector 32, 160030, Chandigarh,
GMCH, sector 32, 160030, Chandigarh,
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8894286467 |
| Fax |
|
| Email |
drpankaj.kr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pryas Jain |
| Designation |
Junior resident, Paediatrics |
| Affiliation |
Government medical college, Chandigarh |
| Address |
Dept. Of Paediatrics, 4th floor, B block, GMCH, sector 32, 160030, Chandigarh,
Dept. Of Paediatrics, 4th floor, B block, GMCH, sector 32, 160030, Chandigarh,
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9988651512 |
| Fax |
|
| Email |
pryj2609@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Dept. Of Paediatrics, 4th floor, B block, GMCH, sector 32, 160030, Chandigarh, |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pryas Jain |
Government Medical College And Hospital, Chandigarh |
Department of Paediatrics, Peadiatric Emergency Ward
Chandigarh
CHANDIGARH |
9988651512
pryj2609@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Dexamethasone in a dosage of 0.3mg/kg/day (Max: 16mg/day)
Frequency: Once daily
Route: Oral
Duration: 2 days |
| Comparator Agent |
Prednisolone |
Prednisolone, in a dosage of 1mg/kg/day
Frequency: Once daily
Route: Oral
Duration: 5 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children between the ages of 2 years to less than 18 years hospitalized with acute exacerbation of asthma. |
|
| ExclusionCriteria |
| Details |
Life threatening exacerbation requiring PICU admissions.
Known hypersensitivity to dexamethasone or prednisolone.
Chronic comorbidities (e.g., congenital heart disease, immunodeficiencies).
Prior corticosteroid use in the last 30 days
Children already enrolled in the study and presenting within 30 days of discharge from hospital.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean PRAM scores |
Baseline (admission) and day 4 of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Respiratory Assessment Measure, measured 6 hourly till discharge or transfer from emergency department |
6 hourly till discharge |
| Length of hospital stay |
admission to discharge |
| Incidence of adverse effects |
admission to discharge |
| Unscheduled visits to hospital due to symptoms of exacerbation asthma within 60 days of administration of steroids |
discharge to 60 days after discharge |
| Persistence of symptoms after 7 days of discharge. |
discharge till 7 days after discharge |
| Duration of admission in emergency department |
admission to discharge |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute exacerbation contributes to the morbidity, mortality, poor quality of life and cost of asthma. Not much changes have been done in the standard treatment regimen hence therapeutic approaches need to be improved. Recent studies have shown that dexamethasone is a safer alternative to prednisolone and but the results regarding its use in emergency setting is inconclusive and their potential role in acute exacerbation has been unexplored. In this study, the patients will receive either dexamethasone or prednisolone and outcomes like length of hospital stay, PRAM score at admission, on day 4 and 6 hourly till the time of discharge, adverse effects, symptoms persisting at 7 days after admission, number of exacerbations requiring unplanned visits to hospital within 60 days of giving the medication, compliance, adverse effects experienced. And in case of any adverse effects if observed, patients will be immediately shifted to the standard regimen of treatment. |