Back to resultsEFFECTIVENESS OF SINGLE DOSE ORAL DEXAMETHASONE VERSUS MULTIDOSE PREDNISOLONE FOR TREATMENT OF ACUTE EXACERBATIONS OF ASTHMA AMONG CHILDREN ATTENDING THE EMERGENCY DEPARTMENT OF CHILDREN HOSPITAL, ISLAMABAD
Primary Purpose
Asthma in Children
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dexamethasone
Prednisolone
Sponsored by
About this trial
This is an interventional other trial for Asthma in Children
Eligibility Criteria
Inclusion Criteria: i.Ages 2 to 12years ii. Previous history of asthma as diagnosed by a physician. iii. Presentation with acute exacerbation of asthma with symptoms of cough, wheeze, dyspnoea and oxygen saturation of less than 95% and with PRAM score of more than or equal to 6 Exclusion Criteria: i.Critical or life-threatening asthma i.e. patient with silent chest, cyanosis, drowsy, unable to verbalize, marked tachycardia and respiratory distress. ii.Known TB exposure iii.Fever more than 39. 5°C iv.Use of corticosteroids in previous 4 weeks v.Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric
Sites / Locations
- Asim Nawaz Niazi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral Single dose dexamethsone in acute exacerbation of asthma
Oral Multidose Prednisolone in acute exacerbation of asthma
Arm Description
Outcomes
Primary Outcome Measures
Improvement in PRAM score
PRAM will be evaluated at day 4
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05850143
Brief Title
EFFECTIVENESS OF SINGLE DOSE ORAL DEXAMETHASONE VERSUS MULTIDOSE PREDNISOLONE FOR TREATMENT OF ACUTE EXACERBATIONS OF ASTHMA AMONG CHILDREN ATTENDING THE EMERGENCY DEPARTMENT OF CHILDREN HOSPITAL, ISLAMABAD
Official Title
EFFECTIVENESS OF SINGLE DOSE ORAL DEXAMETHASONE VERSUS MULTIDOSE PREDNISOLONE FOR TREATMENT OF ACUTE EXACERBATIONS OF ASTHMA AMONG CHILDREN ATTENDING THE EMERGENCY DEPARTMENT OF CHILDREN HOSPITAL, ISLAMABAD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 26, 2019 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
December 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DR. MOHAMMAD ALI ARIF
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this Study i'll compare the effectiveness of two drugs used in acute exacerbation of asthma by their sideffects, complaince and improvement in the PRAM score. The better one would be adapted in our clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Single dose dexamethsone in acute exacerbation of asthma
Arm Type
Active Comparator
Arm Title
Oral Multidose Prednisolone in acute exacerbation of asthma
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Oral Dexamethasone a longer and potent corticosteroid with lesser sideffects and good compliance
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral Multidose Prednisolone
Primary Outcome Measure Information:
Title
Improvement in PRAM score
Description
PRAM will be evaluated at day 4
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
i.Ages 2 to 12years ii. Previous history of asthma as diagnosed by a physician. iii. Presentation with acute exacerbation of asthma with symptoms of cough, wheeze, dyspnoea and oxygen saturation of less than 95% and with PRAM score of more than or equal to 6
Exclusion Criteria:
i.Critical or life-threatening asthma i.e. patient with silent chest, cyanosis, drowsy, unable to verbalize, marked tachycardia and respiratory distress. ii.Known TB exposure iii.Fever more than 39. 5°C iv.Use of corticosteroids in previous 4 weeks v.Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric
Facility Information:
Facility Name
Asim Nawaz Niazi
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
EFFECTIVENESS OF SINGLE DOSE ORAL DEXAMETHASONE VERSUS MULTIDOSE PREDNISOLONE FOR TREATMENT OF ACUTE EXACERBATIONS OF ASTHMA AMONG CHILDREN ATTENDING THE EMERGENCY DEPARTMENT OF CHILDREN HOSPITAL, ISLAMABAD
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