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Status unknownNCT05850143Updated May 9, 2023

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

An interventional study of Dexamethasone and Prednisolone in Asthma in Children, sponsored by DR. MOHAMMAD ALI ARIF. Status unknown at 1 site in Pakistan. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by DR. MOHAMMAD ALI ARIF · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Jan 2019, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma in Children

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 192 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

This is the only study on the registry with DR. MOHAMMAD ALI ARIF as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study arms

  • Active comparator
    Oral Single dose dexamethsone in acute exacerbation of asthma

    Drug: Dexamethasone

  • Active comparator
    Oral Multidose Prednisolone in acute exacerbation of asthma

    Drug: Prednisolone

Interventions

  • DrugDexamethasone

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

  • DrugPrednisolone

    Oral Multidose Prednisolone

06

What researchers measure

Primary outcomes

  1. Improvement in PRAM score

    PRAM will be evaluated at day 4

    Time frame: 4 days

07

Study locations

1 site
  • Asim Nawaz Niazi
    Islamabad, 46000, Pakistan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05850143
Lead sponsor
DR. MOHAMMAD ALI ARIF
Responsible party
DR. MOHAMMAD ALI ARIF (Docter, Shaheed Zulfiqar Ali Bhutto Medical University) — Sponsor-investigator
First posted
May 9, 2023
Start date
Jan 26, 2019
Primary completion
Dec 26, 2023 (estimated)
Completion
Dec 26, 2023 (estimated)
Last update
May 9, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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