Multicenter trial of effectiveness and safety of bronchial thermoplasty in bronchial asthma
Not Applicable
Recruiting
- Conditions
- Bronchial asthma
- Registration Number
- JPRN-UMIN000025244
- Lead Sponsor
- Japanese Red Cross Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients using a body defibrillator such as a pacemaker or ICD 2) Patients who have previously received bronchial thermoplasty (BT) 3) Patients with severe complications such as heart disease, liver disease or kidney failure 4) Patients with respiratory infection, blood coagulation disorder 5) Patients who had exacerbation of asthma or dose change of oral corticosteroids in the past 14 days 6) Patients who can not use drugs required for bronchoscopic procedures such as lidocaine, atropine, benzodiazepine type anxiolytic drugs 7) Patients with bronchial asthma-COPD overlap syndrome (ACOS) 8) Other patients judged unsuitable as subjects by doctor's judgment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of adverse events of Grade 3 or higher onset occurring within 90 days after the final treatment
- Secondary Outcome Measures
Name Time Method 1. Incidence rate of adverse events of Grade 1 or higher after each treatment 2. Asthma control after each treatment (ratio of number of strokes per week, rate of unscheduled outpatient visits in 1 week (including emergency outpatient visit)) 3. Drug reduction effect after final treatment 4. Change in bronchial wall thickening after each treatment 5. Each treatment time 6. Activation count for each treatment 7. Adverse events of Grade 1 or higher from primary evaluation to 1 year after the last treatment