Bronchial AsthmaPhase 2/3Mg in asthmaNCT06721247
Oral Intake of Mg in Controlled Asthmatic Patients
A Phase 2/3 study testing Magnesium and ICS+LABA in people with Bronchial Asthma, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the efficacy of oral magnesium supplements in controlled asthmatic patients for proper effective asthma management to reduce frequency of asthma exacerbation \& to test the effect of oral magnesium supplementation on improvement of both clinical symptoms and lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Magnesium and ICS+LABA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2024to 2 Nov 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Stable controlled asthmatic patients .
Who cannot join
- Medical conditions and disorders (such as chronic kidney disease, diabetes mellitus, cardiac disease, alcoholism, diarrhea, and pregnancy).
- Any treatment which might affect the absorption or excretion of Mg2+ including digoxin, diuretics, and calcium-containing medications.
- Patients in asthma exacerbations .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Oral Magnesium Supplementation in Controlled Bronchial Asthma Patients
The goal of this clinical trial is to assess the efficacy of oral magnesium supplements in controlled asthmatic patients for proper effective asthma management to reduce frequency of asthma exacerbation \& to test the effect of oral magnesium supplementation on improvement of both clinical symptoms and lung functions in patients with bronchial asthma.. The main questions it aims to answer are:
- Can oral supplementation of magnesium play a role in decrease the number of bronchial asthma exacerbations , number of ER visits , number of doctor visits and improve lung function ? Researchers will compare patients on usual treatment according to GINA guidelines 2024 group B and those taking oral magnesium together with the usual group A .
Read more
Participants will:
- Take oral magnesium treatment with usual asthma medications according to GINA guidelines (2024) every day for 1year
- Visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their day and night symptoms and the number of times they had activity limitation due to asthma and the number of use reliever.
Read the detailed description
Asthma is one of the main non-communicable chronic diseases and affects a huge portion of the population. It is a multifactorial disease, classified into several phenotypes, being the allergic the most frequent. The pathophysiological mechanism of asthma involves a Th2-type immune response, with high concentrations of allergen-specific immunoglobulin E, eosinophilia, hyperreactivity and airway remodeling. These mechanisms are orchestrated by intracellular signaling from effector cells, such as lymphocytes and eosinophils. Ion channels play a fundamental role in maintaining the inflammatory response on asthma.The mainstay of management is a beta-agonist and corticosteroids inhaler. However, new investigations into the pathogenesis of the disease are emerging. For example, many reports have observed that low blood levels and low dietary intake of magnesium are factors that possibly contribute to the development of asthma. In addition, low levels of magnesium have been detected in asthmatics compared with non-asthmatics, especially those that have presented to the emergency department with exacerbations.The role of intravenous and inhaled magnesium in the management of acute asthma has been extensively studied and the guidelines are well established. IV or inhaled routes can be used as a last resort for severe, persistent asthma that fails to respond to conventional treatment. Nevertheless, oral magnesium is not included in these guidelines. so on, this study has these objectives : To detect any disturbance in magnesium blood level in patients with controlled bronchial asthma . 2. To compare frequency of asthma exacerbations in asthma controlled patients in patients who will be treated with oral magnesium supplementations and those who will not receive it . 3. To determine if oral magnesium supplementation is an adjunctive from the start for adequate effective control of bronchial asthma. 4. To determine the relationship between oral magnesium supplementation and FEV1 improvement .
- Conditions
- Bronchial Asthma
- Being tested
- Magnesium, ICS+LABA
- Keywords
- bronchial asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
oral intake of magnesium for asthmatic patients with dose 200 mg per day for one year in addition to usual asthmatic treatment according to GINA guidelines 2024
ICS+LABADrug
inhaled corticosteroids with long acting Beta 2 agonist are given to control group patients twice daily
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | oral magnesium intake is given to bronchial asthma patients together with the usual asthma medication according to GINA guidelines 2024 Receives: Drug: Magnesium; Drug: ICS+LABA |
| control group | Placebo comparator | asthmatic patients who take the usual asthma treatment according to GINA guideline 2024 Receives: Drug: ICS+LABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in the degree of asthma control
By using GINA assessment of symptom control and future risk including 1) decrease daytime symptoms of asthma. 2) decrease use of relievers . 3)improvement in daily activities. 4) decrease night awakening due to asthma symptoms .
By using pulmonary function tests (Spirometer) specially Forced expiratory volume in the first second (FEV1) , any improvement in pulmonary function will be measured .
Measured: 6 months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start2 Nov 2024
- Primary completion2 Nov 2025 (estimated)
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanaa Sami Hamed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721247
- Sponsor's protocol ID
- ZU-IRB#11325-3/12-2023
- Acronym
- Mg in asthma
- Status last verified
- Aug 2025
- First submitted
- 3 Dec 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Oral Magnesium Supplementation in Controlled Bronchial Asthma Patients
- ClinicalTrials.gov ID
- NCT06721247
- Acronym / sponsor ID
- Mg in asthma / ZU-IRB#11325-3/12-2023
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 2 Nov 2025 (estimated)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 6 Dec 2024 (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.
The goal of this clinical trial is to assess the efficacy of oral magnesium supplements in controlled asthmatic patients for proper effective asthma management to reduce frequency of asthma exacerbation \& to test the effect of oral magnesium supplementation on improvement of both clinical symptoms and lung functions in patients with bronchial asthma.. The main questions it aims to answer are:
- Can oral supplementation of magnesium play a role in decrease the number of bronchial asthma exacerbations , number of ER visits , number of doctor visits and improve lung function ? Researchers will compare patients on usual treatment according to GINA guidelines 2024 group B and those taking oral magnesium together with the usual group A .
Participants will:
- Take oral magnesium treatment with usual asthma medications according to GINA guidelines (2024) every day for 1year
- Visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their day and night symptoms and the number of times they had activity limitation due to asthma and the number of use reliever.
Detailed description
Asthma is one of the main non-communicable chronic diseases and affects a huge portion of the population. It is a multifactorial disease, classified into several phenotypes, being the allergic the most frequent. The pathophysiological mechanism of asthma involves a Th2-type immune response, with high concentrations of allergen-specific immunoglobulin E, eosinophilia, hyperreactivity and airway remodeling. These mechanisms are orchestrated by intracellular signaling from effector cells, such as lymphocytes and eosinophils. Ion channels play a fundamental role in maintaining the inflammatory response on asthma.The mainstay of management is a beta-agonist and corticosteroids inhaler. However, new investigations into the pathogenesis of the disease are emerging. For example, many reports have observed that low blood levels and low dietary intake of magnesium are factors that possibly contribute to the development of asthma. In addition, low levels of magnesium have been detected in asthmatics compared with non-asthmatics, especially those that have presented to the emergency department with exacerbations.The role of intravenous and inhaled magnesium in the management of acute asthma has been extensively studied and the guidelines are well established. IV or inhaled routes can be used as a last resort for severe, persistent asthma that fails to respond to conventional treatment. Nevertheless, oral magnesium is not included in these guidelines. so on, this study has these objectives : To detect any disturbance in magnesium blood level in patients with controlled bronchial asthma . 2. To compare frequency of asthma exacerbations in asthma controlled patients in patients who will be treated with oral magnesium supplementations and those who will not receive it . 3. To determine if oral magnesium supplementation is an adjunctive from the start for adequate effective control of bronchial asthma. 4. To determine the relationship between oral magnesium supplementation and FEV1 improvement .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Drug: Magnesium, Drug: ICS+LABAoral magnesium intake is given to bronchial asthma patients together with the usual asthma medication according to GINA guidelines 2024 |
| control group | Placebo comparator | Drug: ICS+LABAasthmatic patients who take the usual asthma treatment according to GINA guideline 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years.
- Stable controlled asthmatic patients .
Key exclusion criteria (3 listed)
- Medical conditions and disorders (such as chronic kidney disease, diabetes mellitus, cardiac disease, alcoholism, diarrhea, and pregnancy).
- Any treatment which might affect the absorption or excretion of Mg2+ including digoxin, diuretics, and calcium-containing medications.
- Patients in asthma exacerbations .
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 |
|---|---|---|
| Magnesiumoral intake of magnesium for asthmatic patients with dose 200 mg per day for one year in addition to usual asthmatic treatment according to GINA guidelines 2024 | Drug | intervention group |
| ICS+LABAinhaled corticosteroids with long acting Beta 2 agonist are given to control group patients twice daily | Drug | control group, intervention group |
Primary outcome
improvement in the degree of asthma control
Time frame: 6 months to one year
By using GINA assessment of symptom control and future risk including 1) decrease daytime symptoms of asthma. 2) decrease use of relievers . 3)improvement in daily activities. 4) decrease night awakening due to asthma symptoms . By using pulmonary function tests (Spirometer) specially Forced expiratory volume in the first second (FEV1) , any improvement in pulmonary function will be measured .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- 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?
A Phase 2/3 study testing Magnesium and ICS+LABA in people with Bronchial Asthma, run by Zagazig 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 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
improvement in the degree of asthma control (time frame: 6 months to one year). 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 14 Aug 2025.