Overview

This trial is active, not recruiting.

Conditions asthma, aged
Treatments magnesium, education for asthma action plan, hot-lines for acute exacerbation of asthma, inhaler technique training
Sponsor Sang-Heon Cho
Collaborator Korean Center for Disease Control and Prevention
Start date June 2012
End date June 2016
Trial size 360 participants
Trial identifier NCT01843439, H-1205-083-410

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(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. 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 500mg per day)
magnesium Product name - Magnes
education for asthma action plan
hot-lines for acute exacerbation of asthma
inhaler technique training

Primary Outcomes

Measure
Number of acute exacerbation of asthma
time frame: 1 year from enrollment

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 65 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.