Status:
COMPLETED
Hyperpolarized Magnetic Resonance Imaging in Asthma Pre- and Post-Bronchial Thermoplasty
Lead Sponsor:
Dr. Grace Parraga
Collaborating Sponsors:
McMaster University
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Patients in London and Hamilton with severe asthma who are deemed eligible by a respirologist to undergo bronchial thermoplasty treatment will be randomized to image-guided or conventional bronchial t...
Detailed Description
This is a one year, single centre randomized controlled trial. Subjects will be identified through the London Asthma Centre located at St. Joseph's Hospital and from Hamilton at St. Joseph's Healthcar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02263794
Start Date
October 1 2014
End Date
September 1 2020
Last Update
May 12 2023
Active Locations (2)
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1
McMaster University
Hamilton, Ontario, Canada, L8S 4L8
2
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, Canada, N6A 5B7