Bronchial Ablation for Treatment of Asthma (BATA) Trial

NCT03765307 | Active Not Recruiting DMC

• 1 other identifier: 201801
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 15

Brief Summary

To evaluate the safety and efficacy of a bronchial radiofrequency ablation system (SyMap Medical (Suzhou) Ltd) in a population of subjects with severe asthma who are still symptomatic despite being managed on high-dose Inhaled Corticosteroids (ICS) and Long-Acting β2-adrenergic Agonists (LABA).

Conditions

Asthma

Keywords

Asthma; Bronchial Ablation; Bronchial Thermoplasty

Outcome Measures

Primary Outcomes (1)

• Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)

  Definition of severe asthma exacerbations: 1. Patients who do not receive oral corticosteroids maintenance, systemic corticosteroids (tablets, suspensions or injections) need to be used, or ICS doses doubled, due to increased asthma symptoms. 2. Patients who have been treated with oral corticosteroids maintenance daily or every other day, the daily dose of systemic corticosteroids needs to be increased, due to increased asthma symptoms; Note: Severe asthma exacerbations of the above described two conditions, after treatment with corticosteroids, stabilized for 1 week or more, then recurring asthma symptoms will be counted as a single severe asthma exacerbations.

  12 months

Secondary Outcomes (8)

• Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline

  3, 6, 12, 24, 36, 48 and 60 months

• Asthma Quality of Life Questionnaire Score (AQLQ)

  6 weeks, 3, 6, 12, 24, 36, 48 and 60months

• Modified Asthma Control Questionnaire (ACQ-6) Score

  6 weeks, 3, 6, 12, 24, 36, 48 and 60months

• Percent of Symptom-Free Days

  12 months

• Numbers of severe asthma exacerbations

  6 weeks, 12, 24, 36, 48 and 60 months

Other Outcomes (7)

• Emergency Room Visits days

  12, 24, 36, 48 and 60 months

• Hospitalization days

  12, 24, 36, 48 and 60 months

• Absence of work/school due to asthma symptoms, or days affecting daily actives

  12 months

Study Arms (2)

SyMap Bronchial Ablation Group

EXPERIMENTAL

The experimental group is treated using SyMap Bronchial Radiofrequency Ablation system, including disposable bronchial radiofrequency ablation catheter (Model: BA125T) and Bronchial radiofrequency ablation instrument (Model: ELATION S3).

Device: SyMap Bronchial Ablation System

Boston Scientific Bronchial Thermoplasty Group

ACTIVE COMPARATOR

The control group is treated using Boston Scientific Alair System, including Bronchial radiofrequency ablation catheter Alair (Model: ATS2-5 ) and Bronchial radiofrequency ablation instrument (Model: ATS200)

Device: Boston Scientific Alair System

Interventions

SyMap Bronchial Ablation System DEVICE

The Bronchial Ablation is performed using SyMap Bronchial Ablation System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.

SyMap Bronchial Ablation Group

Boston Scientific Alair System DEVICE

The Bronchial Thermoplasty is performed using Boston Scientific Alair System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.

Boston Scientific Bronchial Thermoplasty Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is an adult between the ages of 18 to 65 years;
• Diagnosed with asthma who required regular asthma maintenance medication in the past 6 months as follows:
• ICS ≥1000 μg/day beclomethasone or equivalent and LABA ≥1000μg /day salmeterol or equivalent.
• Other medications were allowed, including leukotriene modifiers, and Oral Corticosteroids (OCS) ≤ 10mg/day.
• At least two days of asthma symptoms during 4-weeks of the baseline period.
• Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 45% of predicted.
• Non-smoker (less than 10 pack per year) last for 1 year or greater.
• Baseline AQLQ Score less than or equal to 6.25
• Willingness and ability to comply with the outpatient follow-up.

You may not qualify if:

• Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of less than 45% of predicted.
• or more hospitalizations for exacerbations of asthma in the past 12 months;
• More than 3 lower respiratory tract infections requiring antibiotics in the past 12 months
• More than 4 of oral steroid use for exacerbations of asthma in the past 12 months
• Chronic sinusitis
• Uncontrolled gastroesophageal reflux disease, defined as a significant increase in treatment over the past 6 weeks
• Sensitivity to medications required to perform bronchoscopy (such as lidocaine and benzodiazepines)
• Use of an implantable electrical stimulation device, such as a pacemaker, a cardiac defibrillator or a deep nerve or deep brain stimulator;
• Severe emphysema caused by chronic obstructive pulmonary disease (COPD).
• Use of systemic immunosuppressants, beta adrenergic blockers, or anticoagulants.
• History of fatal asthma.
• Uncontrolled obstructive sleep apnea
• Intubation or admission to the ICU for asthma exacerbations within 2 years prior to treatment
• Hemorrhagic or malignant tumors or Coagulopathy.
• Lower bronchial stenosis or distal complete atelectasis or other severe bronchial and pulmonary lesions, as Thoracic spiral CT showed

Sponsors & Collaborators

• SyMap Medical (Suzhou), Ltd.: lead
• JieNuo Medical(Beijing)Co.,Ltd: collaborator

Study Sites (15)

Chinese Pla General Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

University of Chinese Academy of Sciences Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Hebei Chest Hospital

Shijiazhuang, Hebei, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Third Affiliated Hospital Of Qiqihar Medical University

Qiqihar, Heilongjiang, China

Location

The First Affilated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Location

Northern Theater Command General Hospital

Shenyang, Liaoning, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Shiyue LI, MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The enrolled patients are blinded until 12 months after procedure. Physicians who perform post-procedure patient management and physicians who perform bronchial ablation/ bronchial thermoplasty procedures are blinded to each other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with severe asthma are assigned to the experimental or control group at a 1:1 ratio based on a central randomized system.

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: December 5, 2018
• Study Start: June 18, 2019
• Primary Completion: August 15, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

CN (15)