Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Asthma Clinical Trial

Official title:

Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856959
• Other study ID #: MS-2013CQ
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: May 17, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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 ß2-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Magnesium Sulfate
2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg
• magnesium sulfate & albuterol
0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg
• Albuterol
0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg

Locations

Country	Name	City	State
China	Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	10 min and 20 min post-dose	Yes
Secondary	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.	20 min	Yes