Topic: Respiratory
Conditions
Interventions
3He, 129Xe and 1H MRI imaging, Functional lung MRI with hyperpolarised (HP) gas MRI (Helium-3 and Xenon-129 MRI) and 1H perfusion MRI before and after thermoplasty to explore the relation between chan
Sponsors
University of Leicester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Males and females of any race who are over the age of 18 years at the time informed the consent is obtained 3. Physician diagnosis of asthma, as per Global Initiative for Asthma (GINA) guidelines and currently prescribed inhaled corticosteroid (ICS) or inhaled corticosteroid-long-acting beta agonist (ICS-LABA) therapy GINA step 3 to step 5 asthma therapies 4. Patients assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan
Exclusion criteria
Exclusion criteria: 1. Patients who are considered unsuitable for inclusion by the assessing physician due to serious co-morbidities such as cancer, emphysema or significant bronchiectasis 2. Recent (within 4 weeks of visit 1) or current lower respiratory tract infection 3. A positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or subject?s verbal report 4. A positive human immunodeficiency virus test or is taking anti-retroviral medications, as determined by medical history and/or subject?s verbal report Additional exclusion criteria for patients who have agreed to take part in the MR Imaging part of the study 4.1. Patients with a contra-indication to MRI scanning: i.e. patients who are non MRI compatible (ferro-magnetic metallic implants, pacemakers) as per the MRI questionnaire 4.2. Patients with potential adverse reactions to Gd-DTPA intravascular MRI contrast agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in immunopathological features following thermoplasty; Timepoint(s): Before thermoplasty, 3 weeks post thermoplasty and 6 weeks post thermoplasty | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed