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
Sponsor
DR. MOHAMMAD ALI ARIF (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05850143
Collaborator
(none)
192
1
2
59
3.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
192 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date
:
Jan 26, 2019
Anticipated Primary Completion Date
:
Dec 26, 2023
Anticipated Study Completion Date
:
Dec 26, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Oral Single dose dexamethsone in acute exacerbation of asthma
|
Drug: Dexamethasone
Oral Dexamethasone a longer and potent corticosteroid with lesser sideffects and good compliance
|
| Active Comparator: Oral Multidose Prednisolone in acute exacerbation of asthma
|
Drug: Prednisolone
Oral Multidose Prednisolone
|
Outcome Measures
Primary Outcome Measures
- Improvement in PRAM score [4 days]
PRAM will be evaluated at day 4
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asim Nawaz Niazi | Islamabad | Pakistan | 46000 |
Sponsors and Collaborators
- DR. MOHAMMAD ALI ARIF
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
DR. MOHAMMAD ALI ARIF,
Docter,
Shaheed Zulfiqar Ali Bhutto Medical University
ClinicalTrials.gov Identifier:
NCT05850143
Other Study ID Numbers:
- ERB/SZABMU/2021-192
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: