Asthma AttackNCT05908864
Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation
An observational study of Asthma Attack, run by Beni-Suef University at 1 site in Egypt.
Trial summary
A prospective study in Beni-Seuf University Hospital that was conducted on 123 adult patients with acute asthma exacerbations. Patients were classified into group (I): received IV magnesium sulfate, group (II): received nebulized magnesium sulfate, and group (III): control group. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma Attack
- What is being tested?
- Magnesium sulfate
- How many people
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2018to 15 Dec 2020
- 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
- No healthy volunteers
- Adult
Study population: 131 patients were included in the study.Eight subjects were excluded due to presence of heart failure or renal failure.
Who may be able to join
- adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma
- From both sexes
- Normal Renal function
- Normal Cardiovascular function
Who cannot join
- Patients were younger than 18 years or older than 50 years.
- Patients suffered from chronic obstructive pulmonary disease
- Patidnts suffered from renal disorder
- Patients with heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation
A prospective study in Beni-Seuf University Hospital that was conducted on 123 adult patients with acute asthma exacerbations. Patients were classified into group (I): received IV magnesium sulfate, group (II): received nebulized magnesium sulfate, and group (III): control group. Blood pressure, respiratory rate, pulse, peak expiratory flow rate (PEFR) measurement using a peak flowmeter, Fischl index and need for hospitalization in patients with acute bronchial asthma were done for all patients before treatment, immediately after the treatment, "30", and "60" min after treatment.
Read the detailed description
Inclusion criteria :
- adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma
- from both sexes
- Normal renal function
- Normal cardiovascular function
Exclusion criteria:
- Patients were younger than 18 years or older than 50 years.
- Patients suffered from chronic obstructive pulmonary disease, renal disorder and heart failure
All patients were subjected to: complete history taking, blood sampling for serum magnesium measurement (on admission before the initial treatment and after the initial treatment) the patients were randomly separated into 3 equal groups each group consists of 41 patients.
The 1ST group has been managed by an initial treatment plan (consists of supplemental oxygen therapy to keep oxygen saturation higher than 90%., nebulization of 1 ml salbutamol respirator solution mixed with 9 ml normal saline solution for one session [Farcolin respirator solution: each 20 ml of Farcolin contains Salbutamol sulfate 0.121 gm. Made in Egypt, by: Pharco Pharmaceuticals -Alexandria], Intravenous administration of hydrocortisone 100 mg for a single dose [Solu-Cortef: vial contains powder of 100 mg Sodium hydrocortisone sodium succinate dissolved with 2 ml solvent of sterile bacteriostatic water for IV injection. Manufactured by: Egyptian Int. Pharmaceutical Industries co. (e.i.p.i.co.) - Egypt. Under license of: Pfizer]) plus a single dose (2000 mg) of magnesium sulfate prepared by mixing 20 ml of 10 % magnesium sulfate (2000 MG) [14] ,manufactured by Memphis Pharmaceuticals and Chemical Industries, with 30 ml of distillated water for injection to produce 50 ml of isotonic magnesium sulfate solution (324 MSOM/L) administered intravenously over 1 hour.
The 2nd group has been managed by the same initial treatment plan plus a single dose (2000 mg) of magnesium sulfate prepared by mixing 20 ml of 10 % magnesium sulfate (2000 MG) [14] ,manufactured by Memphis Pharmaceuticals and Chemical Industries, with 30 ml of distillated water to produce 50 ml of isotonic magnesium sulfate solution (324 MSOM/L). nebulized using jet nebulizer over 1 hour.
The 3rd group has been managed by the same treatment plan Without using magnesium sulfate. (a control group) the following were recorded for each patient at a fixed interval (before the initial treatment, immediately after the initial treatment, 30, and 60 min after the initial treatment):
- blood pressure, respiratory rate and pulse rate
- Peak expiratory flow measurement using peak flow meter.
- Fischl index for relapse and need for hospitalization in patients with acute bronchial asthma. [16[ .
- Conditions
- Asthma Attack
- Being tested
- Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Blood pressure, respiratory rate, pulse, peak expiratory flow rate (PEFR) measurement using a peak flowmeter, Fischl index and need for hospitalization in patients with acute bronchial asthma were done
| Study group | Role | What they receive |
|---|---|---|
| IV Magnesium Sulfate | Not described Receives: Drug: Magnesium sulfate | |
| Inhaled Magnesium Sulfate | Not described Receives: Drug: Magnesium sulfate | |
| Control group | Not described Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving pulmonary function tests as PEFR for asthmatic patients
Prevention of the progression asthma exacerbation for included subjects
Measured: 13 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start30 Oct 2018
- Primary completion22 Nov 2019
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AttackStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda R.S. Hussein, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908864
- Sponsor's protocol ID
- #FWA00015574
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nebulized Versus Intravenous Magnesium Sulfate in Treatment of Asthma Exacerbation
- ClinicalTrials.gov ID
- NCT05908864
- Acronym / sponsor ID
- #FWA00015574
- Conditions
- Asthma Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 18 Jun 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.
A prospective study in Beni-Seuf University Hospital that was conducted on 123 adult patients with acute asthma exacerbations. Patients were classified into group (I): received IV magnesium sulfate, group (II): received nebulized magnesium sulfate, and group (III): control group. Blood pressure, respiratory rate, pulse, peak expiratory flow rate (PEFR) measurement using a peak flowmeter, Fischl index and need for hospitalization in patients with acute bronchial asthma were done for all patients before treatment, immediately after the treatment, "30", and "60" min after treatment.
Detailed description
Inclusion criteria :
- adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma
- from both sexes
- Normal renal function
- Normal cardiovascular function
Exclusion criteria:
- Patients were younger than 18 years or older than 50 years.
- Patients suffered from chronic obstructive pulmonary disease, renal disorder and heart failure
All patients were subjected to: complete history taking, blood sampling for serum magnesium measurement (on admission before the initial treatment and after the initial treatment) the patients were randomly separated into 3 equal groups each group consists of 41 patients.
The 1ST group has been managed by an initial treatment plan (consists of supplemental oxygen therapy to keep oxygen saturation higher than 90%., nebulization of 1 ml salbutamol respirator solution mixed with 9 ml normal saline solution for one session [Farcolin respirator solution: each 20 ml of Farcolin contains Salbutamol sulfate 0.121 gm. Made in Egypt, by: Pharco Pharmaceuticals -Alexandria], Intravenous administration of hydrocortisone 100 mg for a single dose [Solu-Cortef: vial contains powder of 100 mg Sodium hydrocortisone sodium succinate dissolved with 2 ml solvent of sterile bacteriostatic water for IV injection. Manufactured by: Egyptian Int. Pharmaceutical Industries co. (e.i.p.i.co.) - Egypt. Under license of: Pfizer]) plus a single dose (2000 mg) of magnesium sulfate prepared by mixing 20 ml of 10 % magnesium sulfate (2000 MG) [14] ,manufactured by Memphis Pharmaceuticals and Chemical Industries, with 30 ml of distillated water for injection to produce 50 ml of isotonic magnesium sulfate solution (324 MSOM/L) administered intravenously over 1 hour.
The 2nd group has been managed by the same initial treatment plan plus a single dose (2000 mg) of magnesium sulfate prepared by mixing 20 ml of 10 % magnesium sulfate (2000 MG) [14] ,manufactured by Memphis Pharmaceuticals and Chemical Industries, with 30 ml of distillated water to produce 50 ml of isotonic magnesium sulfate solution (324 MSOM/L). nebulized using jet nebulizer over 1 hour.
The 3rd group has been managed by the same treatment plan Without using magnesium sulfate. (a control group) the following were recorded for each patient at a fixed interval (before the initial treatment, immediately after the initial treatment, 30, and 60 min after the initial treatment):
- blood pressure, respiratory rate and pulse rate
- Peak expiratory flow measurement using peak flow meter.
- Fischl index for relapse and need for hospitalization in patients with acute bronchial asthma. [16[ .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV Magnesium Sulfate | – | Drug: Magnesium sulfate |
| Inhaled Magnesium Sulfate | – | Drug: Magnesium sulfate |
| Control group | – | Drug: Magnesium sulfate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 131 patients were included in the study.Eight subjects were excluded due to presence of heart failure or renal failure.
Key inclusion criteria (4 listed)
- adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma
- From both sexes
- Normal Renal function
- Normal Cardiovascular function
Key exclusion criteria (4 listed)
- Patients were younger than 18 years or older than 50 years.
- Patients suffered from chronic obstructive pulmonary disease
- Patidnts suffered from renal disorder
- Patients with heart failure.
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 |
|---|---|---|
| Magnesium sulfateBlood pressure, respiratory rate, pulse, peak expiratory flow rate (PEFR) measurement using a peak flowmeter, Fischl index and need for hospitalization in patients with acute bronchial asthma were done | Drug | Control group, IV Magnesium Sulfate, Inhaled Magnesium Sulfate |
Primary outcome
Improving pulmonary function tests as PEFR for asthmatic patients
Time frame: 13 monthes
Prevention of the progression asthma exacerbation for included subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Attack, run by Beni-Suef University at 1 site in Egypt.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improving pulmonary function tests as PEFR for asthmatic patients (time frame: 13 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.