Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China

Moderate Asthma Clinical Trial

Official title:

Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965807
• Other study ID #: 2015-17
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 9, 2016
• Last updated: November 14, 2016
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Guangzhou Institute of Respiratory Disease
• Contact: yanqiuzi cheng
• Phone: 15915709477
• Email: 736145682[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Moderate Asthma

Intervention

Device:
• Bronchial Thermoplasty
patients will be under Bronchial Thermoplasty approximately every three weeks.And totally having three surgerys will be considered as completed.

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

References & Publications (8)

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 — View 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. — View 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( — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes