Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
9 participants
INTERVENTIONAL
2014-02-28
2015-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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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
Principal Investigators
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Sei Won Lee, MD
Role: PRINCIPAL_INVESTIGATOR
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
Locations
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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, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Thermoplasty-Br
Identifier Type: -
Identifier Source: org_study_id
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