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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02263794
Eligibility Criteria:
Inclusion Criteria:
* Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
* Male and female aged 18-60 years of age with a clinical diagnosis of asthma, as per:
* Beta-agonist reversibility of FEV1\>12%, OR
* Methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving ICS or ≤ 16mg/ml if receiving an ICS.
* Subject has asthma and is taking regular maintenance medication for the past 12 months that includes:
* Inhaled corticosteroid (ICS)
* Long-acting beta agonist (LABA)
* Other asthma medication such as leukotriene modifier, or anti-IgE, are acceptable
* FEV1 \> 50%pred pre-bronchodilator
* Subject assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan
* Subject is a non-smoker for 1 year or greater (if former smoker less than 10 pack years total smoking history).
* Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
* Subject is judged to be in otherwise stable health on the basis of medical history
Exclusion Criteria:
* Subject is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
* Subject is unable to perform spirometry or plethysmography maneuvers
* Subject is pregnant
* Recent (within 4 weeks of BL Visit 1) or current asthma exacerbation and/or respiratory tract infection
* Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.) (At the discretion of the MRI Technologist/3T Manager)
* In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02263794
Study Brief:
Protocol Section:
NCT02263794