The effect of inhaled magnesium sulfate on the duration of hospitalization and spirometry indicators in patients with chronic obstructive pulmonary disease
Determination of the effect of inhaled magnesium sulfate on the length of hospital stay and spirometric indices during exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Design
This is a phase 2 randomized clinical trial with parallel groups and single-blind design (patients blinded), conducted on 174 patients with COPD. Participants are randomly assigned to the intervention and control groups using the rand function in Excel.
Settings and conduct
This clinical trial will be conducted on 348 patients aged 30 to 70 years with acute exacerbation of COPD at Shahid Beheshti Hospital, Kashan University of Medical Sciences. Patients are randomly assigned using block randomization to receive either standard treatment or standard treatment plus inhaled magnesium sulfate, and clinical and paraclinical outcomes will be assessed according to the study protocol.
Participants/Inclusion and exclusion criteria
Participants:
Individuals with a previous diagnosis of COPD who have been admitted to the hospital due to an acute exacerbation, or whose COPD has been diagnosed through spirometry and have an FEV1 ≤ 80% or FEV1/FVC < 70%.
Intervention:
Individuals with a previous diagnosis of COPD who have been admitted to the hospital due to an acute exacerbation and have had their COPD diagnosed through spirometry. In addition to the standard pharmacological treatment regimen for acute exacerbations, this group will receive inhaled magnesium sulfate.
Intervention groups
The control group receives only the standard treatment for acute COPD exacerbation. The intervention group, in addition to the standard treatment, also receives inhaled magnesium sulfate via nebulizer
Main outcome variables
Length of hospital stay; Interval to rehospitalization (up to 6 months); Improvement in FEV1 based on spirometry after 5 days; CRP level (quantitative, after 5 days)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250528065953N1
Registration date:2025-07-21, 1404/04/30
Registration timing:prospective
Last update:2025-07-21, 1404/04/30
Update count:0
Registration date
2025-07-21, 1404/04/30
Registrant information
Name
Amir Dasdar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9258
Email address
amirdasdar72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-01, 1404/05/10
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhaled magnesium sulfate on the duration of hospitalization and spirometry indicators in patients with chronic obstructive pulmonary disease
Public title
Inhaled magnesium sulfate in COPD (Chronic Obstructive Pulmonary Diseases)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with a history of COPD who have been hospitalized due to acute exacerbations
Individuals who have been diagnosed with COPD through spirometry
Individuals who have an FEV1 of 80% or lower and/or an FEV1/FVC ratio of less than 70%.
Exclusion criteria:
Pneumonia
Malignancy
CHF (Congestive Heart Failure)
Astham
Hospitalization for a reason other than chronic obstructive pulmonary disease (COPD) exacerbation.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
384
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was used, with the individual as the unit of randomization. To randomly assign participants to the study groups, a block randomization method with blocks of four was applied. The blocks included the following sequences: (AABB), (BBAA), (BABA), (ABAB), (ABBA), and (BAAB), where "A" represents the treatment group and "B" represents the placebo group. The selection of blocks was performed using the RandInt function in Microsoft Excel.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since an objective measurement tool is used in the study, the risk of bias is minimized. Additionally, a placebo will not be used, as all patients receive standard bronchodilator therapy via nebulizer during treatment. Therefore, only the clinical data analyst and outcome assessor will be blinded to the treatment allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Medicine & Faculty of Dentistry – Kashan University of Medi
Chronic obstructive pulmonary disease with (acute) exacerbation
Primary outcomes
1
Description
Length of Hospital stay
Timepoint
Once, at the time of the patient's discharge.
Method of measurement
Patient medical records
2
Description
FEV1/FVC
Timepoint
Baseline and after 5 days
Method of measurement
with Spirometry
Secondary outcomes
1
Description
Admission Interval
Timepoint
Up to 6 month after the primary discharge
Method of measurement
Based on the patient's medical record
2
Description
GOLD
Timepoint
On each admission time
Method of measurement
Based on Spirometry and GOLD criteria
3
Description
FEV1
Timepoint
Baseline (from the admission) and 5 days after admission
Method of measurement
Spirometry
Intervention groups
1
Description
Intervention group: The other 118 patients, in addition to receiving standard treatment, will be administered ready-to-use vials of inhaled magnesium sulfate via nebulizer at a dose of 1 gram every 12 hours for five days.
Category
Treatment - Drugs
2
Description
Control group: 118 patients will receive standard treatment for acute exacerbation of COPD, which includes supplemental oxygen (if oxygen saturation is below 88% in patients without a cardiac history), bronchodilators (salbutamol administered via nebulizer or MDI depending on the patient's condition), systemic corticosteroids at the standard COPD dose (35 to 40 mg of prednisolone or its equivalent), and broad-spectrum antibiotics for five days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital, Kashan
Full name of responsible person
Yazdan Jafari
Street address
Pezeshk Blvd., Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9347
Email
Jafari-y@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Pezeshk Blvd., Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9347
Email
g.hamidi@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Dasdar
Position
Internal medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Pezeshk Blvd., Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9347
Email
Dasdar-A@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Yazdan Jafari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Pezeshk Blvd., Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9347
Email
Jafari-A@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Dasdar
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Pezeshk Blvd., Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9347
Email
Dasdar-A@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be fully accessible only after ensuring the anonymity of the participants.
When the data will become available and for how long
6 months after publication
To whom data/document is available
Every individual who send his/her request to corresponding author and corresponding author confirm his/her access
Under which criteria data/document could be used
the purpose is to ensure the proper conduct of the study and to use the data for more accurate future research."
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Send email to corresponding author - assessment of the request and confirm/reject the access