Asthma
Conditions
Brief summary
The investigators will find out if bronchial thermoplasty shows efficacy in reducing acute exacerbation and improving quality of life for uncontrolled asthma in Korea through this research. US FDA approved this procedure and CE mark was taken in Europe. Many procedure was performed in Western countries. Korean FDA have approved this procedure in 2013. However, no procedure was performed in Korea, and the data is rare in Asian countries. In this study, investigators will examine the efficacy of this procedure in Korean asthmatics.
Interventions
PROCEDUREbronchial thermoplasty system
Check on the quality of life, emergency room uses, and sudden progress of the disease of the patients before and after the treatment by using bronchial thermoplasty system by using paired t test.
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Eighteen-year-old or older * 2\) Patients whose asthma is not controlled with more than three months of using high dose inhaled steroids and long acting β2-agonists * 3\) Patients with pre-bronchodilator FEV1 is between sixty and eighty-five% * 4\) Patients who do not improve through continuous drug uses.
Exclusion criteria
* 1\) Presence of a pacemaker, internal defibrillator, or other implantable electronic devices, * 2\) Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines. * 3\) Patients previously treated with the Alair System should not be retreated in the same area(s). No clinical data are available studying the safety and/or effectiveness of repeat treatments. * 4)Active respiratory infection * 5\) Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days. * 6\) Known coagulopathy. * 7\) As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin and NSAIDS before the procedure with physician guidance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA | 6 months | — |
| Acute exacerbation | 3,and 6 months | Acute exacerbation of asthma is defined as following: episodes of progressive increase in shortness of breath, cough, wheezing, or chest tightness, or some combination of these symptoms leading change of medications (use of systemic steroids or antibiotics) |
Countries
South Korea
Contacts
Primary ContactSei Won Lee, MD
Outcome results
None listed