NCT06171932

Brief Summary

COMPARISON OF EFFICACY OF HYDROCORTISONE AND METHYLPREDNISOLONE IN ACUTE SEVERE ASTHMA In this study Investigator will compare the efficacy of hydrocortisone and methyl prednisolone in acute severe asthma that will lead to final result and beneficial effects that will help in early resoloution of symptoms and help in preventing recurrence

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

November 24, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

November 26, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

November 24, 2023

Last Update Submit

December 12, 2023

Conditions

Asthma Acute

Outcome Measures

Primary Outcomes (5)

  • Spirometry

    Above will be check on arrival of patient to Emergency and post Managment

    24 hours

  • Blood pressures

    Vital signs at initial presentation and post managment will be recorded Blood pressure in mm HG will be recorded

    24 hours

  • Respiratory rate

    Respiratory rate at arrival and post managment will be considered Respiratory rate in Breaths/min

    24 hours

  • Heart rate

    Heart rate beats/min will be checked

    24 hours

  • PEAK EXPIRATORY FLOW RATE

    it wil be checked on arrival and post managment in Peak Expiratory Flow rate (force expiratory volume in 1 second and force vital capacity )will be examined

    24 hours

Study Arms (2)

HYDROCORTISONE

Group A will comprise of 30 patients will be treated with 200 mg hydrocortisone followed by 3 doses of hydrocortisone 100 mg 6 hours apart for next 24hrs

METHYLPREDNISOLONE

Group B will be treated with methylprednisolone 125 mg stat

Drug: Methylprednisolone,

Interventions

Methylprednisolone,DRUG

No intervention required

Also known as: Hydrocortisone
METHYLPREDNISOLONE

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

60 30 in each group

You may qualify if:

  • Either Gender (18 to 50 years old)
  • Patient presenting to emergency department with acute severe asthma

You may not qualify if:

  • Patients with critical illness or pregnant females. .Patient treated other than hydrocortisone and methylprednisolone. .Patients not willing to participate in study.
  • Life threatening asthma
  • Near fatal asthm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Zia ud din hospital university

Karachi, Sindh, 09323, Pakistan

Location

Zia ud din university hospital

Karachi, Sindh, 09323, Pakistan

Location

Zia ud din university hospitals

Karachi, Sindh, Pakistan

Location

Zia ud din university

Karachi, Sindh, Pakistan

Location

Related Publications (1)

  • Aggarwal P, Bhoi S. Comparing the efficacy and safety of two regimens of sequential systemic corticosteroids in the treatment of acute exacerbation of bronchial asthma. J Emerg Trauma Shock. 2010 Jul;3(3):231-7. doi: 10.4103/0974-2700.66522.

    PMID: 20930966RESULT

Related Links

MeSH Terms

Interventions

MethylprednisoloneHydrocortisone

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnenedionesPregnenes11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Inayat ur Rehman, MD ER

    zia ud din university karachi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 15, 2023

Study Start

November 26, 2023

Primary Completion

August 1, 2024

Study Completion

August 8, 2024

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

PERFORMA OF PATIENTS AND DATA TAKEN FROM HOSPITAL OF KARACHI WILL BE SHARED AS WELL RESULT OUTCOME WILL BE SHARED IT WILL INCLUDE STUDY PROTOCOL STATS INFORMED CONSENT CLINICAL STUDY REPORT

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 MONTHS
Access Criteria
IPD CRITERIA WILL SHARE WHEN REQUIRED DIRECTLY FROM INVESTIGASTOR

Locations

PA(4)