An observational study examining airway remodelling and repair in patients with severe persistent asthma treated with bronchial thermoplasty: an imaging and immunopathological study

niversity of Leicester (UK)0 sites20 target enrollmentStarted: July 16, 2013Last updated: February 26, 2018

Conditions

Trial Snapshot

No summary available.

•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

•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

Sponsor

niversity of Leicester (UK)