AsthmaNCT01843439
Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation
A study testing Magnesium, Education for asthma action plan and hot-lines for acute exacerbation of asthma in people with Asthma and Aged, run by Sang-Heon Cho at 1 site in South Korea.
Trial summary
We want to examine the effect of multidisciplinary interventions in asthma patients who had experienced acute exacerbation of asthma. In our previous observational studies, elderly asthma patients had a some distinct features such as impairment of cognitive function, deficiency of micronutrient and absence of… Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Magnesium, Education for asthma action plan and hot-lines for acute exacerbation of asthma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elderly asthma patients who had experienced acute exacerbation of asthma
- 1)aggravations of any of major criteria
- dyspnea
- cough
- wheezing
- increase or purulent changes of sputum
Show all 11Show fewer
- nocturnal symptoms
- 2)aggravation of more than one of following criteria
- a reduction of forced expiratory volume at one second or peak expiratory flow rate more than 20% compared than one's best score
- unscheduled clinic or emergency department visit or admission
- step-up of dose of asthma medications or any intake of systemic steroids
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-460
About this study
We want to examine the effect of multidisciplinary interventions in asthma patients who had experienced acute exacerbation of asthma.
In our previous observational studies, elderly asthma patients had a some distinct features such as impairment of cognitive function, deficiency of micronutrient and absence of caregiver compared with young adult asthmatics.
Read more
We wanted to evaluate whether the long-term course of asthma could be modified by intervening deficienies which were found in elderly patiensts.
So, we designed a interventional study to correct above risk factors in elderly asthma patients, which could be aggravating their asthma. Followings are our specific multidiciplinary items that we want to correct.
- popularize and educate the asthma action plan
- run a emergency call system for acute exacerbation
- educate the proper techniques using inhalers
- correct the deficiency of magnesium (magnesium 500 mg per day)
After 1 years, we will measure the numbers of acute exacerbations, lung function including FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study patients.
- Being tested
- Magnesium, Education for asthma action plan, hot-lines for acute exacerbation of asthma, Inhaler technique training
- Keywords
- Acute exacerbation, Quality of life, Magnesium deficiency, Multidisciplinary intervention
- Medical subject headings
- Asthma, Magnesium Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDietary supplement
Also called Product name - Magnes, Composition - Magnesium Lactate 470mg, Pyridoxine HCl 5mg, Company - Daewha pharmaceutical
Education for asthma action planBehavioural
hot-lines for acute exacerbation of asthmaBehavioural
Inhaler technique trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | We designed a intervention study to correct additional risk factors in elderly asthma patients.
We offer following specific interventions simultaneously to intervention arm and will measure the effects of interventions after 1 years.
1. popularize and educate the asthma action plan
2. run a emergency call system for acute exacerbation
3. educate the proper techniques using inhalers
4. correct the deficiency of magnesium (magnesium 500mg per day) Receives: Dietary Supplement: Magnesium; Behavioral: Education for asthma action plan; Behavioral: hot-lines for acute exacerbation of asthma; Behavioral: Inhaler technique training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute exacerbation of asthma
measure the existence of acute exacerbation when they visit the clinic at 3, 6, 12 month after enrollment
Measured: 1 year from enrollment
Secondary outcomes (4)
Pulmonary function test
measure when subjects visits the clinic at 3, 6, 12 month after enrollment
Measured: 1 year after enrollment
Asthma control status
measure when subjects visit the clinic at 3, 6, 12 month after enrollment
Measured: one year from enrollment
asthma quality of life questionnaire
measure when subjects visit the clinic at 3, 6, 12 month after enrollment
Measured: one year from enrollment
serum magnesium level
measure when subjects visit the clinic at 3, 6, 12 month after enrollment
Measured: one year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2016 (estimated)
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sang-Heon Cho
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Sang-Heon Cho, Seoul National University Hospital
- Investigators
- Sang-Heon Cho, MD./PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843439
- Sponsor's protocol ID
- H-1205-083-410
- Status last verified
- Apr 2013
- First submitted
- 26 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation
- ClinicalTrials.gov ID
- NCT01843439
- Acronym / sponsor ID
- H-1205-083-410
- Keywords
- Acute exacerbation, Quality of life, Magnesium deficiency, Multidisciplinary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Sang-Heon ChoUniversity, hospital or other
- Collaborators
- Korean Center for Disease Control and Prevention
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (estimated)
- First posted
- 30 Apr 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.
We want to examine the effect of multidisciplinary interventions in asthma patients who had experienced acute exacerbation of asthma.
In our previous observational studies, elderly asthma patients had a some distinct features such as impairment of cognitive function, deficiency of micronutrient and absence of caregiver compared with young adult asthmatics.
We wanted to evaluate whether the long-term course of asthma could be modified by intervening deficienies which were found in elderly patiensts.
So, we designed a interventional study to correct above risk factors in elderly asthma patients, which could be aggravating their asthma. Followings are our specific multidiciplinary items that we want to correct.
- popularize and educate the asthma action plan
- run a emergency call system for acute exacerbation
- educate the proper techniques using inhalers
- correct the deficiency of magnesium (magnesium 500 mg per day)
After 1 years, we will measure the numbers of acute exacerbations, lung function including FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Magnesium, Behavioral: Education for asthma action plan, Behavioral: hot-lines for acute exacerbation of asthma, Behavioral: Inhaler technique trainingWe designed a intervention study to correct additional risk factors in elderly asthma patients. We offer following specific interventions simultaneously to intervention arm and will measure the effects of interventions after 1 years. 1. popularize and educate the asthma action plan 2. run a emergency call system for acute exacerbation 3. educate the proper techniques using inhalers 4. correct the deficiency of magnesium (magnesium 500mg per day) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- elderly asthma patients who had experienced acute exacerbation of asthma
- 1)aggravations of any of major criteria
- dyspnea
- cough
- wheezing
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MagnesiumAlso: Product name - Magnes, Composition - Magnesium Lactate 470mg, Pyridoxine HCl 5mg, Company - Daewha pharmaceutical | Dietary supplement | Intervention |
| Education for asthma action plan | Behavioural | Intervention |
| hot-lines for acute exacerbation of asthma | Behavioural | Intervention |
| Inhaler technique training | Behavioural | Intervention |
Primary outcome
Number of acute exacerbation of asthma
Time frame: 1 year from enrollment
measure the existence of acute exacerbation when they visit the clinic at 3, 6, 12 month after enrollment
4 secondary outcomes
Pulmonary function test
Time frame: 1 year after enrollment
Asthma control status
Time frame: one year from enrollment
asthma quality of life questionnaire
Time frame: one year from enrollment
serum magnesium level
Time frame: one year from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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.
Sang-Heon Cho, MD./PhD study chair
Seoul National University Hospital
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, Education for asthma action plan and hot-lines for acute exacerbation of asthma in people with Asthma and Aged, run by Sang-Heon Cho at 1 site in South Korea.
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 11 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 30 Apr 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 South Korea. 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?
Results are not available in the source record.
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?
Number of acute exacerbation of asthma (time frame: 1 year from enrollment). 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 30 Apr 2013.