Bronchial Ablation for Treatment of Asthma (BATA) Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Other trials for the same condition
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