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Bronchial Ablation for Treatment of Asthma (BATA) Trial

NCT03765307 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2019-06-18
Last updated
2023-08-02

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

SyMap Bronchial Ablation SystemBoston Scientific Alair System

SyMap Bronchial Ablation System: 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.

Boston Scientific Alair System: 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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of less than 45% of predicted. * 3 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 * Poor compliance judged by the investigator, or other medical conditions that are not suitable for the study * Related contraindications for bronchoscopy * Pregnant, lactating women, or patients with a birth plan in the next year * Previously undergone bronchial thermoplasty

Primary outcome measure(s)

  • Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year) — 12 months
    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.

Trial sites (15)

FacilityCityRegionStatus
Chinese Pla General Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
University of Chinese Academy of Sciences Shenzhen Hospital Shenzhen Guangdong
Hebei Chest Hospital Shijiazhuang Hebei
The Second Hospital of Hebei Medical University Shijiazhuang Hebei
The Third Affiliated Hospital Of Qiqihar Medical University Qiqihar Heilongjiang
The First Affilated Hospital with Nanjing Medical University Nanjing Jiangsu
Suzhou Municipal Hospital Suzhou Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
Northern Jiangsu People's Hospital Yangzhou Jiangsu
Northern Theater Command General Hospital Shenyang Liaoning
Yantai Yuhuangding Hospital Yantai Shandong
Shanghai Tenth People's Hospital Shanghai Shanghai Municipality
Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University Xi’an Shanxi
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang

More SyMap Medical (Suzhou), Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03765307 on ClinicalTrials.gov ↗ ← All trials in China