AsthmaNCT01799109
Lung Function of Asthmatic Children by Nebulized MgSO4
A study testing Magnesium Sulfate & albuterol, albuterol and magnesium in people with Asthma, run by Chongqing Medical University at 1 site in China.
Trial summary
Asthma is a common chronic respiratory illness which results in frequent wheezing, cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy, β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Magnesium Sulfate & albuterol, albuterol and magnesium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Mar 2012
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- asthmatic children with controlled clinical manifestation
Who cannot join
- fever
- history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
- allergic to acetylcholine, albuterol or magnesium
- use any bronchodilator agents before the Clinic day
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: Lung Function Changes of Mild to Moderate Asthmatic Children Treated by Nebulized MgSO4
Asthma is a common chronic respiratory illness which results in frequent wheezing, cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy, β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma exacerbation, there are still some asthmatic children unresponsive to this management. The Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB provides greater benefit in severe asthma exacerbation.
- Conditions
- Asthma
- Being tested
- Magnesium Sulfate & albuterol, albuterol, magnesium
- Keywords
- magnesium sulfate, nebulization, 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 Sulfate & albuterolDrug
albuterolDrug
magnesiumDrug
| Study group | Role | What they receive |
|---|---|---|
| nebulization ms and albuterol | Experimental | magnesium sulfate 150mg \& albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once Receives: Drug: Magnesium Sulfate & albuterol |
| nebulized albuterol | Active comparator | albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once Receives: Drug: albuterol |
| nebulized ms | Experimental | magnesium sulfate 150mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once Receives: Drug: magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of lung function
to observe changes of Forced expiratory volume in one second and peak expiratory flow in controlled asthmatic children after respectively nebulized MgSO4、albuterol and combination of MgSO4 and albuterol in lung function test.
Measured: 10minutes and 20minutes post-dose
Secondary outcomes (2)
Nebulized magnesium sulfate alone effectively improve lung function
After Ach challenge,FEV1 and PEF decreased in all three groups.But only in albuterol and magnesium group,they presented statistically significant while not in combination therapy group.After each intervention, FEV1 and PEF increased.But there was only statistically significant in FEV1 of magnesium and PEF of albuterol at 10 minutes and these two treatment at 20 minutes
Measured: 10minutes and 20minutes post-dose
the number of participants with adverse events as a measure of safety and tolerability
to observe if anyone appear side effects such as nausea, vomiting, hypotension et al in patients who participating in our experiment. we did not found adverse reaction or other side effect in the study.
Measured: 20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionMar 2012
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
- Single group
- Masking
- None (open label)
- Enrolment
- 90 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, professor, Study director, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799109
- Sponsor's protocol ID
- MS-2012CQ
- Status last verified
- May 2013
- First submitted
- 23 Nov 2012
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function Changes of Mild to Moderate Asthmatic Children Treated by Nebulized MgSO4
- ClinicalTrials.gov ID
- NCT01799109
- Acronym / sponsor ID
- MS-2012CQ
- Conditions
- Asthma
- Keywords
- magnesium sulfate, nebulization, lung function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Feb 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.
Asthma is a common chronic respiratory illness which results in frequent wheezing, cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy, β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma exacerbation, there are still some asthmatic children unresponsive to this management. The Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB provides greater benefit in severe asthma exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nebulization ms and albuterol | Experimental | Drug: Magnesium Sulfate & albuterolmagnesium sulfate 150mg \& albuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once |
| nebulized albuterol | Active comparator | Drug: albuterolalbuterol 2.5mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once |
| nebulized ms | Experimental | Drug: magnesiummagnesium sulfate 150mg nebulized with 5-6L/min of oxygen and consisted about 5 min,which used only once |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- asthmatic children with controlled clinical manifestation
Key exclusion criteria (4 listed)
- fever
- history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
- allergic to acetylcholine, albuterol or magnesium
- use any bronchodilator agents before the Clinic day
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 Sulfate & albuterol | Drug | nebulization ms and albuterol |
| albuterol | Drug | nebulized albuterol |
| magnesium | Drug | nebulized ms |
Primary outcome
changes of lung function
Time frame: 10minutes and 20minutes post-dose
to observe changes of Forced expiratory volume in one second and peak expiratory flow in controlled asthmatic children after respectively nebulized MgSO4、albuterol and combination of MgSO4 and albuterol in lung function test.
2 secondary outcomes
Nebulized magnesium sulfate alone effectively improve lung function
Time frame: 10minutes and 20minutes post-dose
the number of participants with adverse events as a measure of safety and tolerability
Time frame: 20minutes
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 21 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, professor 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 & albuterol, albuterol and magnesium 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 1 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 21 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 (time frame: 10minutes and 20minutes 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 21 May 2013.