Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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
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
Males and females between 21-65 years of age
Stopped smoking for > 1 year and <10 pack-years

Exclusion Criteria

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

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
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
Males and females between 21-65 years of age
Stopped smoking for > 1 year and <10 pack-years

Exclusion Criteria

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

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