Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma

December 12, 2023 updated by: Inayat Ur Rehman, University of Karachi

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

investigator will compare the efficacy of hydrocortisone v/s methylprednisolone in management of patients presented with acute severe asthma in emergency.

A local study was conducted in 2009, after that there is a big research gap exists at national level although international literature is available on the same but it can not be generalized to our population due to socio, geographic and economic differences so there is dire need to conduct this study this gives a strong rationale to implement in our settings

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 09323
        • Zia ud din hospital university
      • Karachi, Sindh, Pakistan, 09323
        • Zia ud din university hospital
      • Karachi, Sindh, Pakistan
        • Zia ud din university hospitals
      • Karachi, Sindh, Pakistan
        • Zia ud din university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

60 30 in each group

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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,
No intervention required
Other Names:
  • Hydrocortisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: 24 hours
Above will be check on arrival of patient to Emergency and post Managment
24 hours
Blood pressures
Time Frame: 24 hours
Vital signs at initial presentation and post managment will be recorded Blood pressure in mm HG will be recorded
24 hours
Respiratory rate
Time Frame: 24 hours
Respiratory rate at arrival and post managment will be considered Respiratory rate in Breaths/min
24 hours
Heart rate
Time Frame: 24 hours
Heart rate beats/min will be checked
24 hours
PEAK EXPIRATORY FLOW RATE
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Karachi

Investigators

  • Principal Investigator: Inayat ur Rehman, MD ER, zia ud din university karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 8, 2024

Study Registration Dates

First Submitted

November 24, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zia ud din university karachi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

6 MONTHS

IPD Sharing Access Criteria

IPD CRITERIA WILL SHARE WHEN REQUIRED DIRECTLY FROM INVESTIGASTOR

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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