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Asthma in ChildrenPhase 3NCT06955559

Magnesium Sulfate in Bronchial Asthma and Acute Bronchiolitis in Children

A Phase 3 study testing Magnesium sulfate in people with Asthma in Children, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Asthma is a prevalent disease that affects as many as334 million individuals worldwide, and is a major source of disability and premature death in children(1). Asthma affects 7.1 million children in the United States (2). Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Asthma in Children
What is being tested?
Magnesium sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 May 2025to 1 Aug 2026
Phase
Phase 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 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • All children more than 1 month and less than 18 years cases with bronchial asthma and acute bronchiolitis

Who cannot join

  • All children less than 1 month and more than 18 years congenital heart disease

About this study

Asthma is a prevalent disease that affects as many as334 million individuals worldwide, and is a major source of disability and premature death in children(1).

Asthma affects 7.1 million children in the United States (2). and is the most common pediatric chronic disease(3).Globally, the prevalence of pediatric asthma varies from 10% to 30%. Its symptoms range from chronic cough to life-threatening bronchospasm.(4,5,6).The most common triggers of asthma exacerbations in both younger and older children are viral respiratory tract infections, exposure to allergens, tobacco smoke, air pollutants, cold or dry air, and poorly controlled asthma(4,7).Current management strategies for acute asthma recommend a stepwise approach, with first-line standard therapy followed by additional therapeutic options(8).Firstline therapy consists of inhaled rapid-acting selective b2-agonists, inhaled ipratropium bromide, and oral or intravenous corticosteroids. Response to standard acute asthma therapy is variable, influenced by factors that cannot be assessed or accounted for urgently such as genetic polymorphisms(9-12).For patients who do not respond adequately to first-line therapy, further improvement can be seen with additional therapy such as inhaled magnesium sulfate (MgSO4) or intravenous aminophylline, terbutaline, or magnesium sulfate. Though all available second-line therapeutic agents produce bronchodilatory effects, magnesium sulfate produces fewer side effects, is more widely available, and costs less than other second-line therapies(13). This combination of efficacy, few side effects, wide availability, and low cost suggest that magnesium sulphate is a promising therapeutic agent that deserves further consideration for use in children with acute asthma. Acute bronchiolitis (AB) is an infection of the lower respiratory tract that is caused by viral agents, especially respiratory syncytial virus, most prevalent in children aged less than 24months(14). It is the most common reason for hospital admissions in the first year of life, representing a significant health burden worldwide. Bronchiolitis usually demonstrates a benign course, most patients are treated as outpatients but progression to severe illness may occur rapidly and respiratory support and admission to pediatric intensive care unit (PICU) may be required promptly in some cases(14). It is characterized by damage of epithelial cells leading to ciliary destruction, airway inflammation, edema, and increased mucus production. Mucus plugs and cellular debris obstruct bronchiolar lumens and result in various degrees of respiratory distress(15). Current recommendations for treatment of AB focus on supportive care, including respiratory support, oxygen supplementation if needed, and adequate hydration. Other treatment agents, such as bronchodilators, hypertonic saline, corticosteroids, and antiviral/antibacterial agents, showed no clearly defined benefit. Only highflow nasal cannula (HFNC) oxygen therapy has been elucidated as a new and promising tool for respiratory support for these patients(16-23).

  • Magnesium sulfate was also investigated as a treatment option for bronchiolitis in few studies
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

    inhaled magnesium sulfate (MgSO4)

Study groups in NCT06955559
Study groupRoleWhat they receive
study groupActive comparatorAll children more than 1 month and less than 18 year cases with bronchial asthma and acute bronchiolitis.
Receives: Drug: Magnesium sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safty of intravenous magnesium sulfate

    Safty of intravenous magnesium sulfate is defined as development of serious adverse events such as hypotension requiring medical intervention.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06955559
Sponsor's protocol ID
Mg bronchialasthma bronchiolis
Status last verified
Apr 2025
First submitted
25 Apr 2025
Last updated
2 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Magnesium sulfate in people with Asthma in Children, run by Assiut University.

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

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?

Safty of intravenous magnesium sulfate (time frame: baseline). 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 2 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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