NCT02031263

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

January 3, 2014

Last Update Submit

August 15, 2014

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (2)

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

    6 months

  • Acute exacerbation

    3,and 6 months

Study Arms (1)

thermoplasty group

EXPERIMENTAL

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

Interventions

bronchial thermoplasty systemPROCEDURE

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.

Also known as: ALAIR
thermoplasty group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Eighteen-year-old or older
  • \) Patients whose asthma is not controlled with more than three months of using high dose inhaled steroids and long acting β2-agonists
  • \) Patients with pre-bronchodilator FEV1 is between sixty and eighty-five%
  • \) Patients who do not improve through continuous drug uses.

You may not qualify if:

  • \) Presence of a pacemaker, internal defibrillator, or other implantable electronic devices,
  • \) Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines.
  • \) 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.
  • )Active respiratory infection
  • \) Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days.
  • \) Known coagulopathy.
  • \) As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin and NSAIDS before the procedure with physician guidance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sei Won Lee, MD

CONTACT

+82-2-3010-3990iseiwon@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 9, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations

KR(1)