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Efficacy of Bronchial Thermoplasty in Korean

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ClinicalTrials.gov Identifier: NCT02031263
Recruitment Status : Unknown
Verified August 2014 by Sei Won Lee, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : January 9, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Sei Won Lee, 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.


Condition or disease Intervention/treatment Phase
Asthma Procedure: bronchial thermoplasty system Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Bronchial Thermoplasty in Korean Patients With Severe Asthma
Study Start Date : February 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: ALAIR




Primary Outcome Measures :
  1. Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA [ Time Frame: 6 months ]
  2. Acute exacerbation [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031263


Contacts
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Contact: Sei Won Lee, MD +82-2-3010-3990 iseiwon@gmail.com

Locations
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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 Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sei Won Lee, MD    +82-2-3010-3990    iseiwon@gmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
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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

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Responsible Party: Sei Won Lee, 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, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02031263     History of Changes
Other Study ID Numbers: Thermoplasty-Br
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases