Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Chongqing Medical University330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

330

Conditions

Asthma

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 10 min and 20 min post-dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: 20 min