Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
- Conditions
- bronchial asthma
- Registration Number
- JPRN-UMIN000035416
- Lead Sponsor
- Tokyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
1)Malignant tumors 2)Severe heart disease 3)Severe hepatic failure 4)Severe renal failure (serum creatinine levels 2.0 or more mg/dl) 5)Current use of a body defibrillator, such as pacemaker or implantable cardioverter defibrillator 6)Active infectious disease 7)Exacerbation of asthma or change in the drug regimen to include oral corticosteroids in the past 14 days 8)Change in the maintenance drug therapy for bronchial asthma in the past 4 weeks 9)Less than 65% post-bronchodilator %FEV1 10)Uncontrolled sinusitis 11)Requirement for oral steroid that is equivalent to more than 10 mg/day of prednisone to control bronchial asthma 12)Past history of intubation or admission to the intensive care unit due to bronchial asthma in the past 24 months 13)Past history in the past 12 months as follows; i) 4 or more infections of the lower respiratory tract, or ii) 3 or more admissions due to respiratory symptoms 14)Has smoked in the past 12 months or has a smoking history of 10 or more pack-years 15)Has previously undergone bronchial thermoplasty 16)Pregnancy or potential pregnancy 17)Judged inadequate to participate in the study by their physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post BT treatment complications, therapeutic control level, pulmonary functions
- Secondary Outcome Measures
Name Time Method