- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01856959
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4
May 17, 2013 updated by: Dai Jihong, Chongqing Medical University
Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
330
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400014
- Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 16 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: nebulized magnesium sulfate
nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once
|
2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg
|
EXPERIMENTAL: nebulized magnesium sulfate & albuterol
nebulized magnesium sulfate 150mg & albuterol 2.5mg and consisted about 5 min,which used only once
|
0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg
|
ACTIVE_COMPARATOR: nebulized albuterol
nebulized albuterol 2.5mg and consisted about 5 min,which used only once
|
0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of lung function after interventions
Time Frame: 10 min and 20 min post-dose
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effectiveness of nebulized magnesium sulfate alone
Time Frame: 10 min and 20 min post-dose
|
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
|
the number of patients with adverse events as a measure of safety and tolerability
Time Frame: 20 min
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jihong Dai, M.D., Chongqing Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
May 14, 2013
First Submitted That Met QC Criteria
May 17, 2013
First Posted (ESTIMATE)
May 20, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
May 20, 2013
Last Update Submitted That Met QC Criteria
May 17, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Adrenergic Agonists
- Membrane Transport Modulators
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
- Magnesium Sulfate
Other Study ID Numbers
- MS-2013CQ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on Magnesium Sulfate
-
Aurora Health CareNot yet recruitingAtrial Fibrillation | Tachycardia Atrial | Atrial Flutter With Rapid Ventricular ResponseUnited States
-
University of OklahomaRecruitingAsthma in Children | Asthma AttackUnited States
-
Thomas Jefferson UniversityNot yet recruiting
-
Sohag UniversityRecruitingPost Operative Pain, AcuteEgypt
-
Sohag UniversityCompletedPersistent Pulmonary Hypertension of the Newborn | PPHN | Persistent Fetal CirculationEgypt
-
Instituto Materno Infantil Prof. Fernando FigueiraCompletedSevere PreeclampsiaBrazil
-
Queen Sirikit National Institute of Child HealthUnknownAcute Severe AsthmaThailand
-
Assiut UniversityRecruitingIntracranial Pressure Control in Pre-eclampsiaEgypt
-
University of Texas Southwestern Medical CenterCompletedAsthmaUnited States
-
University of MonastirCompletedAtrial FibrillationTunisia