Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China

Study Overview
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Brief Summary
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This study aims to investigate the efficacy and safety of Bronchial Thermoplasty on moderate bronchial asthma in China, by observing the improvement of quality of life, the decrease of acute attack and emergence, as well as the incidence of related complications.

Detailed Description
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This is a multi-center, open-label and single arm study. At least 50 patients with moderate asthma receive Bronchial Thermoplasty for three times. Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), Frequency of mild asthma acute attack, PEF, FEV1, Emergency and Hospitalization are compared between before and after BT treatment. The unified peak flow test meter will be provided to all subjects enrolled in this study. They will get a follow-up diary book before leaving hospital. In order to ensure the efficiency, all enrolled asthma patients are trained and tested by doctors and nurses from in-patient or out-patient department when they follow up, including how to use the PEF meter, how to read and record the data. As for the dosage of medication, all the medication uses are followed the doctor's advice, once the rescue medications were used, the times and dosages are mandatory to be recorded in the diary book by the patients themselves.

Official Title
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Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China

Conditions
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Moderate Asthma

Intervention / Treatment
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* Device: Bronchial Thermoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18y and 65y. no improvement after ICS and LABA treatment in patients with moderate asthma have not received BT before stable more than 6 weeks before enrolled in this study no implantable electrical device (e.g. cardiac pacemaker) no permanent anticoagulant is being used Exclusion Criteria: Smoking and have obvious emphysema Chest CT showed lower lobe bronchial stenosis or distal complete atelectasis FEV1 < 65% predicted value after using bronchodilator airway infection(within 6 weeks) any circumstances as the following within the past 1 year: lower respiratory tract infection (LRTI) for 4 times or above; hospitalization due to respiratory diseases for more than 3 times; increase the dosage of oral corticosteroids due to asthma exacerbation for more than 4 times received endotracheal intubation or ICU admission due to asthma attack within the past 2 years concomitant allergic bronchopulmonary aspergillosis Implantable electronic devices (such as cardiac pacemaker)/NYHA class IV and/or acute myocardial infarction within the past 3 months coagulation disorders,cannot stop taking anticoagulant、antiplatelet drugs or nonsteroidal anti-inflammatory drugs increasing the risk of adverse reactions during bronchoscopy or anesthesia as the followings: pregnancy, insulin-dependent diabetes, epilepsy, or the other severe complications, such as uncontrolled coronary heart disease, acute or chronic renal failure or uncontrolled hypertension others:vocal cord dysfunction、chronic nasosinusitis、airway obstruction or uncontrolled obstructive sleep apnea syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchial Thermoplasty<br>Moderate bronchial asthma patients under the Bronchial Thermoplasty. | Device: Bronchial Thermoplasty<br>* patients will be under Bronchial Thermoplasty approximately every three weeks.And totally having three surgerys will be considered as completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline2 AQLQ score after Bronchial Thermoplasty |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decline from baseline 2 in the ACQ score for 0.5 or more |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| Frequency of mild asthma acute execration after Bronchial Thermoplasty | A mild exacerbation is defined as 2 consecutive days when at least one of the following occurs:1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded at the baseline (the first 2 weeks during the 4-week baseline period). 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage at the baseline(the first 2 weeks during the 4-week baseline period). 3. Awakening at night with asthma symptoms. | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| change from baseline2 peak flow after Bronchial Thermoplasty |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| change from baseline2 FEV1 after Bronchial Thermoplasty |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| change from baseline2 FEV1/FVC after Bronchial Thermoplasty |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| change from baseline2 FEV1 predicted after Bronchial Thermoplasty |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| the percentage of Emergency |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| Hospitalization and Asymptomatic days |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 
| the incidence of severe respiratory adverse events |  | baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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China, moderate asthma, Bronchial Thermoplasty