Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

NCT ID: NCT01856959

Last Updated: 2013-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

nebulized magnesium sulfate

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

Group Type: EXPERIMENTAL

Magnesium Sulfate

Intervention Type: DRUG

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

nebulized magnesium sulfate & albuterol

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

Group Type: EXPERIMENTAL

magnesium sulfate & albuterol

Intervention Type: DRUG

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

nebulized albuterol

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

Group Type: ACTIVE_COMPARATOR

Albuterol

Intervention Type: DRUG

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

Interventions

Magnesium Sulfate

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

Intervention Type: DRUG

magnesium sulfate & albuterol

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

Intervention Type: DRUG

Albuterol

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dai Jihong

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihong Dai, M.D.

Role: STUDY_DIRECTOR

Chongqing Medical University

Locations

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

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

MS-2013CQ

Identifier Type: -

Identifier Source: org_study_id