Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

NCT01856959 | Completed

• 1 other identifier: MS-2013CQ
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

magnesium sulfate; nebulized; lung function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• effectiveness of nebulized magnesium sulfate alone

  10 min and 20 min post-dose

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

  20 min

Study Arms (3)

nebulized magnesium sulfate

EXPERIMENTAL

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

Drug: Magnesium Sulfate

nebulized magnesium sulfate & albuterol

EXPERIMENTAL

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

Drug: magnesium sulfate & albuterol

nebulized albuterol

ACTIVE COMPARATOR

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

Drug: Albuterol

Interventions

Magnesium Sulfate DRUG

2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg

nebulized magnesium sulfate

magnesium sulfate & albuterol DRUG

0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg

nebulized magnesium sulfate & albuterol

Albuterol DRUG

0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg

nebulized albuterol

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• known cases of controlled bronchial asthma
• ≧4 years of age
• the result was positive after acetylcholine provocation test in follow-up visit

You may not qualify if:

• 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

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

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

Study Officials

• Jihong Dai, M.D.

  Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 20, 2013
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

CN (1)