Asthma AcuteNCT06171932
Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma
An observational study of Asthma Acute, run by University of Karachi at 4 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma Acute
- What is being tested?
- Methylprednisolone,
- How many people
- 60 participants
- Where
- 4 sitesPakistan
- Study dates
- 26 Nov 2023to 8 Aug 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: 60 30 in each group
Who may be able to join
- Either Gender (18 to 50 years old)
- Patient presenting to emergency department with acute severe asthma
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
Zia ud din hospital university
Karachi, Sindh, 09323
Zia ud din university hospital
Karachi, Sindh, 09323
Zia ud din university hospitals
Karachi, Sindh
Zia ud din university
Karachi, Sindh
About this study
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
Read the 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
- Conditions
- Asthma Acute
- Being tested
- Methylprednisolone,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Hydrocortisone
No intervention required
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Methylprednisolone, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry
Above will be check on arrival of patient to Emergency and post Managment
Measured: 24 hours
Blood pressures
Vital signs at initial presentation and post managment will be recorded Blood pressure in mm HG will be recorded
Measured: 24 hours
Respiratory rate
Respiratory rate at arrival and post managment will be considered Respiratory rate in Breaths/min
Measured: 24 hours
Heart rate
Heart rate beats/min will be checked
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start26 Nov 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion8 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inayat Ur Rehman, University of Karachi
- Investigators
- Inayat ur Rehman, MD ER, Principal investigator, zia ud din university karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171932
- Sponsor's protocol ID
- Zia ud din university karachi
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 20930966
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma
- ClinicalTrials.gov ID
- NCT06171932
- Acronym / sponsor ID
- Zia ud din university karachi
- Conditions
- Asthma Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Study start
- 26 Nov 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 8 Aug 2024 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Methylprednisolone,Group B will be treated with methylprednisolone 125 mg stat |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- 60 30 in each group
Key inclusion criteria (2 listed)
- Either Gender (18 to 50 years old)
- Patient presenting to emergency department with acute severe asthma
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone,Also: HydrocortisoneNo intervention required | Drug | METHYLPREDNISOLONE |
Primary outcome
Spirometry
Time frame: 24 hours
Above will be check on arrival of patient to Emergency and post Managment
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
Respiratory rate
Time frame: 24 hours
Respiratory rate at arrival and post managment will be considered Respiratory rate in Breaths/min
Heart rate
Time frame: 24 hours
Heart rate beats/min will be checked
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Results publication: PubMed 20930966Aggarwal 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.
- ComparisionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inayat ur Rehman, MD ER principal investigator
zia ud din university karachi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Acute, run by University of Karachi at 4 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06171932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.