Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Stable maintenance asthma medications for 4 weeks
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
Pre-bronchodilator FEV1 >60% predicted
...
Stable maintenance asthma medications for 4 weeks
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
Pre-bronchodilator FEV1 >60% predicted
Stopped smoking for > 1 year and <10 pack-years
Males and females between 21-65 years of age

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)
Males and females <21 and >65 years of age
...
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)
Males and females <21 and >65 years of age
Use of immunosuppressant (excluding oral steroids)
Presence of pacemaker, internal defibrillator, or other implantable electronic devices
Known sensitivity to medications required to perform bronchoscopy, including lignocaine and benzodiazepines
Inability to cease antiplatelet or anticoagulant therapy prior to procedure

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

Stable maintenance asthma medications for 4 weeks
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
Pre-bronchodilator FEV1 >60% predicted
...
Stable maintenance asthma medications for 4 weeks
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
Pre-bronchodilator FEV1 >60% predicted
Stopped smoking for > 1 year and <10 pack-years
Males and females between 21-65 years of age

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)
Males and females <21 and >65 years of age
...
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)
Males and females <21 and >65 years of age
Use of immunosuppressant (excluding oral steroids)
Presence of pacemaker, internal defibrillator, or other implantable electronic devices
Known sensitivity to medications required to perform bronchoscopy, including lignocaine and benzodiazepines
Inability to cease antiplatelet or anticoagulant therapy prior to procedure

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
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