Efficacy of Bronchial Thermoplasty in Korean

Phase 4

• Conditions: Asthma
• Interventions: Procedure: bronchial thermoplasty system

• Registration Number: NCT02031263
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Study Start: 2014-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-19
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
thermoplasty group	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA	3 months

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

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, Korea, Republic of