search
Back to results

Efficacy of Bronchial Thermoplasty in Korean

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
bronchial thermoplasty system
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thermoplasty group

Arm Description

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.

Outcomes

Primary Outcome Measures

Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA

Secondary Outcome Measures

Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
Acute exacerbation
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)

Full Information

First Posted
January 3, 2014
Last Updated
August 15, 2014
Sponsor
Asan Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02031263
Brief Title
Efficacy of Bronchial Thermoplasty in Korean
Official Title
Efficacy of Bronchial Thermoplasty in Korean Patients With Severe Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
thermoplasty group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
bronchial thermoplasty system
Other Intervention Name(s)
ALAIR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
Time Frame
6 months
Title
Acute exacerbation
Description
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)
Time Frame
3,and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sei Won Lee, MD
Phone
+82-2-3010-3990
Email
iseiwon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sei Won Lee, MD
Organizational Affiliation
Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sei Won Lee, MD
Phone
+82-2-3010-3990
Email
iseiwon@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Bronchial Thermoplasty in Korean

We'll reach out to this number within 24 hrs