Efficacy of Bronchial Thermoplasty in Korean

Asthma Clinical Trial

Official title:

Efficacy of Bronchial Thermoplasty in Korean Patients With Severe Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02031263
• Other study ID #: Thermoplasty-Br
• Status: Recruiting
• Phase: Phase 4
• First received: January 3, 2014
• Last updated: August 15, 2014
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2014
• Source: Asan Medical Center
• Contact: Sei Won Lee, MD
• Phone: +82-2-3010-3990
• Email: iseiwon[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2-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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA		3 months	No
Secondary	Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA		6 months	No
Secondary	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	No