Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Study Overview
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Brief Summary
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As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of intravenous MgSO4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. At present, there are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma in children, and the conclusions are controversial.

Official Title
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Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail

Conditions
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Asthma

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: magnesium sulfate & albuterol
* Drug: Albuterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: known cases of controlled bronchial asthma ≧4 years of age the result was positive after acetylcholine provocation test in follow-up visit Exclusion Criteria: had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day had fever (axillary temperature>38.5℃) history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nebulized magnesium sulfate<br>nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once | Drug: Magnesium Sulfate<br>* 2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg<br>|
| Experimental: nebulized magnesium sulfate & albuterol<br>nebulized magnesium sulfate 150mg & albuterol 2.5mg and consisted about 5 min,which used only once | Drug: magnesium sulfate & albuterol<br>* 0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg<br>|
| Active Comparator: nebulized albuterol<br>nebulized albuterol 2.5mg and consisted about 5 min,which used only once | Drug: Albuterol<br>* 0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of lung function after interventions | to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate, albuterol, or combination of magnesium sulfate and albuterol respectively. | 10 min and 20 min post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of nebulized magnesium sulfate alone | to observe the changes of the lung function indices(FEV1、PEF) at 10 min and 20 min after inhaling magnesium sulfate alone,and compared it with the patients who was nebulized inhalation albuterol alone. | 10 min and 20 min post-dose | 
| the number of patients with adverse events as a measure of safety and tolerability | to observe if any patient appear side effects or adverse effects like nausea, vomiting, hypotension or the change of deep tendon reflexes et al. | 20 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnesium sulfate, nebulized, lung function