Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Chongqing Medical University

Status: Completed

Conditions: Asthma

Treatments: Drug: magnesium sulfate & albuterol; Drug: Magnesium Sulfate; Drug: Albuterol

Study type: Interventional

Funder types: Other

Identifiers

NCT01856959

MS-2013CQ

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 3 patient groups

nebulized magnesium sulfate

Experimental group

Description:

nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once

Treatment:

Drug: Magnesium Sulfate

nebulized magnesium sulfate & albuterol

Experimental group

Description:

nebulized magnesium sulfate 150mg \& albuterol 2.5mg and consisted about 5 min,which used only once

Treatment:

Drug: magnesium sulfate & albuterol

nebulized albuterol

Active Comparator group

Description:

nebulized albuterol 2.5mg and consisted about 5 min,which used only once

Treatment:

Drug: Albuterol