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Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnesium Sulfate
magnesium sulfate & albuterol
Albuterol
Sponsored by
Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring magnesium sulfate, nebulized, lung function

Eligibility Criteria

4 Years - 16 Years (Child)All SexesAccepts 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

Sites / Locations

  • Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

nebulized magnesium sulfate

nebulized magnesium sulfate & albuterol

nebulized albuterol

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 14, 2013
Last Updated
May 17, 2013
Sponsor
Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01856959
Brief Title
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4
Official Title
Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
magnesium sulfate, nebulized, lung function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nebulized magnesium sulfate
Arm Type
Experimental
Arm Description
nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once
Arm Title
nebulized magnesium sulfate & albuterol
Arm Type
Experimental
Arm Description
nebulized magnesium sulfate 150mg & albuterol 2.5mg and consisted about 5 min,which used only once
Arm Title
nebulized albuterol
Arm Type
Active Comparator
Arm Description
nebulized albuterol 2.5mg and consisted about 5 min,which used only once
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg
Intervention Type
Drug
Intervention Name(s)
magnesium sulfate & albuterol
Intervention Description
0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg
Intervention Type
Drug
Intervention Name(s)
Albuterol
Intervention Description
0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg
Primary Outcome Measure Information:
Title
changes of lung function after interventions
Description
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 Outcome Measure Information:
Title
effectiveness of nebulized magnesium sulfate alone
Description
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
Title
the number of patients with adverse events as a measure of safety and tolerability
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihong Dai, M.D.
Organizational Affiliation
Chongqing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China

12. IPD Sharing Statement

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