NCT05850143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2023

Completed
Last Updated

May 9, 2023

Status Verified

April 1, 2023

Enrollment Period

4.9 years

First QC Date

April 28, 2023

Last Update Submit

May 8, 2023

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

  • Improvement in PRAM score

    PRAM will be evaluated at day 4

    4 days

Study Arms (2)

Oral Single dose dexamethsone in acute exacerbation of asthma

ACTIVE COMPARATOR
Drug: Dexamethasone

Oral Multidose Prednisolone in acute exacerbation of asthma

ACTIVE COMPARATOR
Drug: Prednisolone

Interventions

DexamethasoneDRUG

Oral Dexamethasone a longer and potent corticosteroid with lesser sideffects and good compliance

Oral Single dose dexamethsone in acute exacerbation of asthma
PrednisoloneDRUG

Oral Multidose Prednisolone

Oral Multidose Prednisolone in acute exacerbation of asthma

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asim Nawaz Niazi

Islamabad, 46000, Pakistan

Location

MeSH Terms

Interventions

DexamethasonePrednisolone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Docter

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 9, 2023

Study Start

January 26, 2019

Primary Completion

December 26, 2023

Study Completion

December 26, 2023

Last Updated

May 9, 2023

Record last verified: 2023-04

Locations

PA(1)