Bronchial Ablation for Treatment of Asthma (BATA) Trial

Korábbi kezelés

• More than 4 of oral steroid use for exacerbations of asthma in the past 12 months
• Sensitivity to medications required to perform bronchoscopy (such as lidocaine and benzodiazepines)
• Intubation or admission to the ICU for asthma exacerbations within 2 years prior to treatment
• Previously undergone bronchial thermoplasty

Más betegség

• More than 3 lower respiratory tract infections requiring antibiotics in the past 12 months
• Uncontrolled gastroesophageal reflux disease, defined as a significant increase in treatment over the past 6 weeks
• 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).
• History of fatal asthma.
• Hemorrhagic or malignant tumors or Coagulopathy.
• Poor compliance judged by the investigator, or other medical conditions that are not suitable for the study

Egyéb

• 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;
• Chronic sinusitis
• Use of systemic immunosuppressants, beta adrenergic blockers, or anticoagulants.
• Uncontrolled obstructive sleep apnea
• Lower bronchial stenosis or distal complete atelectasis or other severe bronchial and pulmonary lesions, as Thoracic spiral CT showed
• Related contraindications for bronchoscopy
• Pregnant, lactating women, or patients with a birth plan in the next year

• 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.