Lung Function of Asthmatic Children by Nebulized MgSO4

NCT01799109 | Completed

• 1 other identifier: MS-2012CQ
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a common chronic respiratory illness which results in frequent wheezing, cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy, β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma exacerbation, there are still some asthmatic children unresponsive to this management. The Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB provides greater benefit in severe asthma exacerbation.

Conditions

Asthma

Keywords

magnesium sulfate; nebulization; lung function

Outcome Measures

Primary Outcomes (1)

• changes of lung function

  to observe changes of Forced expiratory volume in one second and peak expiratory flow in controlled asthmatic children after respectively nebulized MgSO4、albuterol and combination of MgSO4 and albuterol in lung function test.

  10minutes and 20minutes post-dose

Secondary Outcomes (2)

• Nebulized magnesium sulfate alone effectively improve lung function

  10minutes and 20minutes post-dose

• the number of participants with adverse events as a measure of safety and tolerability

  20minutes

Study Arms (3)

nebulization ms and albuterol

EXPERIMENTAL

magnesium sulfate 150mg \& albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once

Drug: Magnesium Sulfate & albuterol

nebulized albuterol

ACTIVE COMPARATOR

albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once

Drug: albuterol

nebulized ms

EXPERIMENTAL

magnesium sulfate 150mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once

Drug: magnesium

Interventions

Magnesium Sulfate & albuterol DRUG

nebulization ms and albuterol

albuterol DRUG

nebulized albuterol

magnesium DRUG

nebulized ms

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• asthmatic children with controlled clinical manifestation

You may not qualify if:

• fever
• history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
• allergic to acetylcholine, albuterol or magnesium
• use any bronchodilator agents before the Clinic day

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

Center of Respiratory Disorders,Children's Hospital,Chongqing medical university

Chongqing, Chongqing Municipality, 400014, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Magnesium Sulfate; Albuterol; Magnesium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Metals, Alkaline Earth; Elements; Metals, Light; Metals

Study Officials

• Jihong Dai, professor

  Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: February 26, 2013
• Study Start: November 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

CN (1)