Bronchial Thermoplasty: Mechanism of Action and Defining Asthma Phenotype
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- Pre-bronchodilator FEV1 >60% predicted
- Poorly controlled severe persistent asthma (ACT score < 20) despite high-dose inhaled steroids (>500 mcg fluticasone/day or >800 mcg budesonide/day) in combination with inhaled long-acting Beta-2 agonist and/or anticholinergic agent. Other drugs include leukotriene modifiers, omalizumab (if used for at least 1 year prior), and oral corticosteroids 10mg/day or less
- Stopped smoking for > 1 year and <10 pack-years
- ...
- Pre-bronchodilator FEV1 >60% predicted
- Poorly controlled severe persistent asthma (ACT score < 20) despite high-dose inhaled steroids (>500 mcg fluticasone/day or >800 mcg budesonide/day) in combination with inhaled long-acting Beta-2 agonist and/or anticholinergic agent. Other drugs include leukotriene modifiers, omalizumab (if used for at least 1 year prior), and oral corticosteroids 10mg/day or less
- Stopped smoking for > 1 year and <10 pack-years
- Males and females between 21-65 years of age
- Stable maintenance asthma medications for 4 weeks
Exclusion Criteria
- Patients previously treated with Bronchial Thermoplasty (BT)
- Increased risk of adverse events associated with bronchoscopy or anesthesia (including pregnancy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension)
- Use of immunosuppressant (excluding oral steroids)
- ...
- Patients previously treated with Bronchial Thermoplasty (BT)
- Increased risk of adverse events associated with bronchoscopy or anesthesia (including pregnancy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension)
- Use of immunosuppressant (excluding oral steroids)
- Presence of pacemaker, internal defibrillator, or other implantable electronic devices
- Inability to cease antiplatelet or anticoagulant therapy prior to procedure
- Males and females <21 and >65 years of age
- Known sensitivity to medications required to perform bronchoscopy, including lignocaine and benzodiazepines
Summary
- Conditions
- Asthma
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 64 years
- Gender
- Both males and females
Inclusion Criteria
- Pre-bronchodilator FEV1 >60% predicted
- Poorly controlled severe persistent asthma (ACT score < 20) despite high-dose inhaled steroids (>500 mcg fluticasone/day or >800 mcg budesonide/day) in combination with inhaled long-acting Beta-2 agonist and/or anticholinergic agent. Other drugs include leukotriene modifiers, omalizumab (if used for at least 1 year prior), and oral corticosteroids 10mg/day or less
- Stopped smoking for > 1 year and <10 pack-years
- ...
- Pre-bronchodilator FEV1 >60% predicted
- Poorly controlled severe persistent asthma (ACT score < 20) despite high-dose inhaled steroids (>500 mcg fluticasone/day or >800 mcg budesonide/day) in combination with inhaled long-acting Beta-2 agonist and/or anticholinergic agent. Other drugs include leukotriene modifiers, omalizumab (if used for at least 1 year prior), and oral corticosteroids 10mg/day or less
- Stopped smoking for > 1 year and <10 pack-years
- Males and females between 21-65 years of age
- Stable maintenance asthma medications for 4 weeks
Exclusion Criteria
- Patients previously treated with Bronchial Thermoplasty (BT)
- Increased risk of adverse events associated with bronchoscopy or anesthesia (including pregnancy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension)
- Use of immunosuppressant (excluding oral steroids)
- ...
- Patients previously treated with Bronchial Thermoplasty (BT)
- Increased risk of adverse events associated with bronchoscopy or anesthesia (including pregnancy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension)
- Use of immunosuppressant (excluding oral steroids)
- Presence of pacemaker, internal defibrillator, or other implantable electronic devices
- Inability to cease antiplatelet or anticoagulant therapy prior to procedure
- Males and females <21 and >65 years of age
- Known sensitivity to medications required to perform bronchoscopy, including lignocaine and benzodiazepines
Tracking Information
- NCT #
- NCT02075151
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kay Leong Khoo, MD National University Hospital, Singapore
- Kay Leong Khoo, MD National University Hospital, Singapore