Efficacy of Bronchial Thermoplasty in Korean

Efficacy of Bronchial Thermoplasty in Korean Patients With Severe Asthma

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Procedure: bronchial thermoplasty system

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sei Won Lee, MD; Phone Number: +82-2-3010-3990; Email: iseiwon@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • 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
    • Contact: Sei Won Lee, MD; Phone Number: +82-2-3010-3990; Email: iseiwon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: thermoplasty group; 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.	Procedure: bronchial 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.; Other Names: ALAIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA		6 months
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)	3,and 6 months

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Sei Won Lee, MD, 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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 15, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Thermoplasty-Br