CClinicalTrials.gg
Status unknownNCT01843439Updated Apr 30, 2013

Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation

An interventional study of Magnesium and Education for asthma action plan in Asthma and Aged, sponsored by Sang-Heon Cho. Status unknown at 1 site in Korea, Republic of. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2013-04-30.

Sponsored by Sang-Heon Cho · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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 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.

  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 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.

02

Conditions studied

  • Asthma
  • Aged

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Keywords

  • Acute exacerbation
  • Quality of life
  • Magnesium deficiency
  • Multidisciplinary intervention
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 360 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

This is the only study on the registry with Sang-Heon Cho as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    Intervention

    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)

    Dietary Supplement: Magnesium · Behavioral: Education for asthma action plan · Behavioral: hot-lines for acute exacerbation of asthma · Behavioral: Inhaler technique training

Interventions

  • Dietary supplementMagnesium

    Also known as: Product name - Magnes, Composition - Magnesium Lactate 470mg, Pyridoxine HCl 5mg, Company - Daewha pharmaceutical

  • BehavioralEducation for asthma action plan
  • Behavioralhot-lines for acute exacerbation of asthma
  • BehavioralInhaler technique training
06

What researchers measure

Primary outcomes

  1. Number of acute exacerbation of asthma

    measure the existence of acute exacerbation when they visit the clinic at 3, 6, 12 month after enrollment

    Time frame: 1 year from enrollment

Secondary outcomes

  1. Pulmonary function test

    measure when subjects visits the clinic at 3, 6, 12 month after enrollment

    Time frame: 1 year after enrollment

  2. Asthma control status

    measure when subjects visit the clinic at 3, 6, 12 month after enrollment

    Time frame: one year from enrollment

  3. asthma quality of life questionnaire

    measure when subjects visit the clinic at 3, 6, 12 month after enrollment

    Time frame: one year from enrollment

  4. serum magnesium level

    measure when subjects visit the clinic at 3, 6, 12 month after enrollment

    Time frame: one year from enrollment

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-460, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01843439
Lead sponsor
Sang-Heon Cho
Collaborators
Korean Center for Disease Control and Prevention
Responsible party
Sang-Heon Cho (Professor, Seoul National University Hospital) — Sponsor-investigator
First posted
Apr 30, 2013
Start date
Jun 2012
Primary completion
Jun 2016 (estimated)
Last update
Apr 30, 2013

Study contacts

Sang-Heon Cho, MD./PhD
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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