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Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China

Primary Purpose

Moderate Asthma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Bronchial Thermoplasty
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Asthma focused on measuring Bronchial Thermoplasty, moderate asthma, China

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age between 18y and 65y.
  2. no improvement after ICS and LABA treatment in patients with moderate asthma
  3. have not received BT before
  4. stable more than 6 weeks before enrolled in this study
  5. no implantable electrical device (e.g. cardiac pacemaker)
  6. no permanent anticoagulant is being used

Exclusion Criteria:

  1. Smoking and have obvious emphysema
  2. Chest CT showed lower lobe bronchial stenosis or distal complete atelectasis
  3. FEV1 < 65% predicted value after using bronchodilator
  4. airway infection(within 6 weeks)
  5. 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
  6. received endotracheal intubation or ICU admission due to asthma attack within the past 2 years
  7. concomitant allergic bronchopulmonary aspergillosis
  8. Implantable electronic devices (such as cardiac pacemaker)/NYHA class IV and/or acute myocardial infarction within the past 3 months
  9. coagulation disorders,cannot stop taking anticoagulant、antiplatelet drugs or nonsteroidal anti-inflammatory drugs
  10. 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
  11. others:vocal cord dysfunction、chronic nasosinusitis、airway obstruction or uncontrolled obstructive sleep apnea syndrome

Sites / Locations

  • Guangzhou Institute of Respiratory DiseaseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bronchial Thermoplasty

Arm Description

Moderate bronchial asthma patients under the Bronchial Thermoplasty.

Outcomes

Primary Outcome Measures

change from baseline2 AQLQ score after Bronchial Thermoplasty

Secondary Outcome Measures

decline from baseline 2 in the ACQ score for 0.5 or more
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.
change from baseline2 peak flow after Bronchial Thermoplasty
change from baseline2 FEV1 after Bronchial Thermoplasty
change from baseline2 FEV1/FVC after Bronchial Thermoplasty
change from baseline2 FEV1 predicted after Bronchial Thermoplasty
the percentage of Emergency
Hospitalization and Asymptomatic days
the incidence of severe respiratory adverse events

Full Information

First Posted
November 9, 2016
Last Updated
November 14, 2016
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT02965807
Brief Title
Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China
Official Title
Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Asthma
Keywords
Bronchial Thermoplasty, moderate asthma, China

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchial Thermoplasty
Arm Type
Experimental
Arm Description
Moderate bronchial asthma patients under the Bronchial Thermoplasty.
Intervention Type
Device
Intervention Name(s)
Bronchial Thermoplasty
Intervention Description
patients will be under Bronchial Thermoplasty approximately every three weeks.And totally having three surgerys will be considered as completed.
Primary Outcome Measure Information:
Title
change from baseline2 AQLQ score after Bronchial Thermoplasty
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Secondary Outcome Measure Information:
Title
decline from baseline 2 in the ACQ score for 0.5 or more
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
Frequency of mild asthma acute execration after Bronchial Thermoplasty
Description
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.
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
change from baseline2 peak flow after Bronchial Thermoplasty
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
change from baseline2 FEV1 after Bronchial Thermoplasty
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
change from baseline2 FEV1/FVC after Bronchial Thermoplasty
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
change from baseline2 FEV1 predicted after Bronchial Thermoplasty
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
the percentage of Emergency
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
Hospitalization and Asymptomatic days
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
Title
the incidence of severe respiratory adverse events
Time Frame
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yanqiuzi cheng
Phone
15915709477
Email
736145682@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shiyue li, director
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yanqiuzi cheng
Phone
15915709477
Email
736145682@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17392308
Citation
Solway J, Irvin CG. Airway smooth muscle as a target for asthma therapy. N Engl J Med. 2007 Mar 29;356(13):1367-9. doi: 10.1056/NEJMe078005. No abstract available.
Results Reference
background
PubMed Identifier
15258133
Citation
Danek CJ, Lombard CM, Dungworth DL, Cox PG, Miller JD, Biggs MJ, Keast TM, Loomas BE, Wizeman WJ, Hogg JC, Leff AR. Reduction in airway hyperresponsiveness to methacholine by the application of RF energy in dogs. J Appl Physiol (1985). 2004 Nov;97(5):1946-53. doi: 10.1152/japplphysiol.01282.2003. Epub 2004 Jul 16.
Results Reference
background
PubMed Identifier
12589343
Citation
Lai CK, De Guia TS, Kim YY, Kuo SH, Mukhopadhyay A, Soriano JB, Trung PL, Zhong NS, Zainudin N, Zainudin BM; Asthma Insights and Reality in Asia-Pacific Steering Committee. Asthma control in the Asia-Pacific region: the Asthma Insights and Reality in Asia-Pacific Study. J Allergy Clin Immunol. 2003 Feb;111(2):263-8. doi: 10.1067/mai.2003.30.
Results Reference
background
PubMed Identifier
15947312
Citation
Miller JD, Cox G, Vincic L, Lombard CM, Loomas BE, Danek CJ. A prospective feasibility study of bronchial thermoplasty in the human airway. Chest. 2005 Jun;127(6):1999-2006. doi: 10.1378/chest.127.6.1999.
Results Reference
result
PubMed Identifier
17392302
Citation
Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. doi: 10.1056/NEJMoa064707.
Results Reference
result
PubMed Identifier
17901415
Citation
Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27.
Results Reference
result
PubMed Identifier
21704887
Citation
Castro M, Rubin A, Laviolette M, Hanania NA, Armstrong B, Cox G; AIR2 Trial Study Group. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14.
Results Reference
result
PubMed Identifier
16456145
Citation
Cox G, Miller JD, McWilliams A, Fitzgerald JM, Lam S. Bronchial thermoplasty for asthma. Am J Respir Crit Care Med. 2006 May 1;173(9):965-9. doi: 10.1164/rccm.200507-1162OC. Epub 2006 Feb 2.
Results Reference
result

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Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China

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