Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02075151
Eligibility Criteria:
Inclusion Criteria:
* Males and females between 21-65 years of age
* 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
* Stable maintenance asthma medications for 4 weeks
* Pre-bronchodilator FEV1 \>60% predicted
Exclusion Criteria:
* Males and females \<21 and \>65 years of age
* Presence of pacemaker, internal defibrillator, or other implantable electronic devices
* Known sensitivity to medications required to perform bronchoscopy, including lignocaine and benzodiazepines
* Patients previously treated with Bronchial Thermoplasty (BT)
* Use of immunosuppressant (excluding oral steroids)
* Increased risk of adverse events associated with bronchoscopy or anesthesia (including pregnancy, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension)
* Inability to cease antiplatelet or anticoagulant therapy prior to procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
64 Years
Study:
NCT02075151
Study Brief:
Protocol Section:
NCT02075151