Efficacy of Bronchial Thermoplasty in Korean

Asan Medical Center

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Procedure: bronchial thermoplasty system

Study type: Interventional

Funder types: Other

Identifiers

NCT02031263

Thermoplasty-Br

Details and patient eligibility

About

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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

thermoplasty group

Experimental group

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.

Treatment:

Procedure: bronchial thermoplasty system