Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Drug: Magnesium Sulfate; Drug: magnesium sulfate & albuterol; Drug: Albuterol

• Registration Number: NCT01856959
• Lead Sponsor: Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-03
• Status Verified: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Study First Posted: 2013-05-20
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nebulized magnesium sulfate	Magnesium Sulfate	nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once
nebulized magnesium sulfate & albuterol	magnesium sulfate & albuterol	nebulized magnesium sulfate 150mg \& albuterol 2.5mg and consisted about 5 min,which used only once
nebulized albuterol	Albuterol	nebulized albuterol 2.5mg and consisted about 5 min,which used only once

Primary Outcome Measures

Name	Time	Method
changes of lung function after interventions	10 min and 20 min post-dose	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.

Secondary Outcome Measures

Name	Time	Method
effectiveness of nebulized magnesium sulfate alone	10 min and 20 min post-dose	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.
the number of patients with adverse events as a measure of safety and tolerability	20 min	to observe if any patient appear side effects or adverse effects like nausea, vomiting, hypotension or the change of deep tendon reflexes et al.

Trial Locations

Locations (1)

Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China