- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02031263
Efficacy of Bronchial Thermoplasty in Korean
Efficacy of Bronchial Thermoplasty in Korean Patients With Severe Asthma
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.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Seoul, Korea, Republiken av, 138-736
- Rekrytering
- 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
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Kontakt:
- Sei Won Lee, MD
- Telefonnummer: +82-2-3010-3990
- E-post: iseiwon@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
Tidsram: 3 months
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3 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
Tidsram: 6 months
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6 months
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Acute exacerbation
Tidsram: 3,and 6 months
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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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3,and 6 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: 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
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Thermoplasty-Br
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