AsthmaNCT01856959
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4
A study testing Magnesium Sulfate, magnesium sulfate & albuterol and Albuterol in people with Asthma, run by Chongqing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Magnesium Sulfate, magnesium sulfate & albuterol and Albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- known cases of controlled bronchial asthma
- ≧4 years of age
- the result was positive after acetylcholine provocation test in follow-up visit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Magnesium Sulfate, magnesium sulfate & albuterol, Albuterol
- Keywords
- magnesium sulfate, nebulized, lung function
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg
magnesium sulfate & albuterolDrug
0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg
AlbuterolDrug
0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg
| Study group | Role | What they receive |
|---|---|---|
| nebulized magnesium sulfate | Experimental | nebulized magnesium sulfate 150mg and consisted about 5 min,which used only once Receives: Drug: Magnesium Sulfate |
| nebulized magnesium sulfate & albuterol | Experimental | nebulized magnesium sulfate 150mg \& albuterol 2.5mg and consisted about 5 min,which used only once Receives: Drug: magnesium sulfate & albuterol |
| nebulized albuterol | Active comparator | nebulized albuterol 2.5mg and consisted about 5 min,which used only once Receives: Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 min and 20 min post-dose
Secondary outcomes (2)
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.
Measured: 10 min and 20 min post-dose
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.
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startNov 2011
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai Jihong, Chongqing Medical University
- Investigators
- Jihong Dai, M.D., Study director, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856959
- Sponsor's protocol ID
- MS-2013CQ
- Status last verified
- May 2013
- First submitted
- 14 May 2013
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail
- ClinicalTrials.gov ID
- NCT01856959
- Acronym / sponsor ID
- MS-2013CQ
- Conditions
- Asthma
- Keywords
- magnesium sulfate, nebulized, lung function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nebulized magnesium sulfate | Experimental | Drug: Magnesium Sulfatenebulized magnesium sulfate 150mg and consisted about 5 min,which used only once |
| nebulized magnesium sulfate & albuterol | Experimental | Drug: magnesium sulfate & albuterolnebulized magnesium sulfate 150mg \& albuterol 2.5mg and consisted about 5 min,which used only once |
| nebulized albuterol | Active comparator | Drug: Albuterolnebulized albuterol 2.5mg and consisted about 5 min,which used only once |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- known cases of controlled bronchial asthma
- ≧4 years of age
- the result was positive after acetylcholine provocation test in follow-up visit
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg | Drug | nebulized magnesium sulfate |
| magnesium sulfate & albuterol0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg | Drug | nebulized magnesium sulfate & albuterol |
| Albuterol0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg | Drug | nebulized albuterol |
Primary outcome
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.
2 secondary outcomes
effectiveness of nebulized magnesium sulfate alone
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihong Dai, M.D. study director
Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate, magnesium sulfate & albuterol and Albuterol in people with Asthma, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of lung function after interventions (time frame: 10 min and 20 min post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.