MRI assessment of COPD Wth SOC w/without daily open-label azithromycin
Research type
Research Study
Full title
129XE MRI ASSESSMENT OF DISEASE PROGRESSION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE TREATED WITH STANDARD-OF-CARE MEDICATIONS WITH OR WITHOUT DAILY OPEN-LABEL AZITHROMYCIN TREATMENT TO PREVENT ACUTE EXACERBATION
IRAS ID
300383
Contact name
Jodie Colvin
Contact email
Sponsor organisation
Genetech, Inc.
Eudract number
2020-000852-36
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
This is a clinical research study to determine if a new lung-imaging test called 129XE Magnetic Resonance Imaging (129Xe MRI) will provide more specific information about changes in lung disease than standard lung function tests currently used to monitor COPD. The 129Xe MRI test uses hyperpolarized (HP) xenon-129 gas (129Xe) to create a 3D mapping of ventilation and gas distribution in the lungs that represents your lung structure and function. This test will be used to monitor for potential changes in your lung structure and/or function that might relate to your respiratory symptoms. The use of 129Xe MRI is investigational. “Investigational” means that these tests have not yet been approved by health authorities and are being tested in research studies like this one.
This study will evaluate 129Xe MRI as a prognostic and diagnostic tool in patients with COPD treated with standard-of-care COPD medications with or without azithromycin (an approved antibiotic drug). The study duration for a given participant will be approx. 1 year with a Screening Period, Treatment Period, and Follow Up Period.
The target study enrolment is approximately 120 patients. Approximately 100 patients with moderate/severe COPD in Cohort A. These 100 patients will be randomly assigned into a 1:1 ratio to either receive Azithromycin plus SOC or SOC alone.
Cohort B is an observational cohort of patients with approximately 20 patients with mild COPD. Patients in Cohort B will receive SOC alone.
Patients enrolled in both Cohort A and Cohort B will be required to complete all the planned study visits and complete a daily diary to record the use of study medications and any unplanned doctor or hospital visits. The study involves procedures including physical examinations, vital signs, ECG, 6-minute walk test, blood and sputum sampling, spirometry and chest scans including x-ray, CT scan and 129XE MRI.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
21/NW/0336
Date of REC Opinion
21 Jan 2022
REC opinion
Further Information Favourable Opinion