An Open Label Oxygen Enhanced Imaging Biomarker Asthma Study
Research type
Research Study
Full title
An Open Label Oxygen Enhanced Imaging Biomarker Study to Assess the Role of Fluticasone/Formoterol upon Airway Function in Moderate to Severe Persistent Asthma.
IRAS ID
160899
Contact name
Salman Siddiqui
Contact email
Sponsor organisation
The University of Leicester
Eudract number
2015-000172-98
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
An Open Label Oxygen Enhanced Imaging Biomarker Study to Assess the Role of Fluticasone/Formoterol upon Airway Function in Moderate to Severe Persistent Asthma.
The pilot research study will evaluate the role of an MRI imaging test(s) using a technique called 'Oxygen Enhanced MRI(OE-MRI)' in asthma. Specifically the study will assess the response of these imaging tests to a licensed asthma inhaler (Fluticasone/Formoteral) in 12 patients with moderate to severe asthma.
The OE-MRI imaging tests will give information about the function the small airways in asthma. The small airways (< 2mm in diameter) account for most of the lung surface area, but they can't be visualised by conventional imaging (e.g CT scanning) and their function can't be captured by conventional breathing tests such as spirometry.
Patients will(after appropriate consent) undergo breathing tests and OE-MRI both before and 30 minutes after the administration of a single dose via spacer of the inhaler. The OE-MRI scans will be evaluated to see how the Formoterol(bronchodilator) component of the inhaler improves the function of the lungs in both large and small airways.
In addition 5 healthy aged match volunteers will have baseline scans a only to optimise the OE-MRI image sequences and analysis.
The study is important because imaging biomarker studies are being increasingly used in early stage drug development and offer the potential of evaluating the impact of drugs in asthma with small patient numbers. In addition the study will give information about the response of the small airways to Formoterol (a common bronchodilator) in asthma. This study will therefore evaluate the potential of OE-MRI imaging biomarkers as inhaler response markers in asthma.
The study will bring together the University of Leicester, NIHR funded Leicester Respiratory Biomedical Research Unit and a leading imaging service provider called BIOXYDYN who have developed a unique package of imaging biomarkers in asthma and COPD.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0087
Date of REC Opinion
24 Mar 2015
REC opinion
Further Information Favourable Opinion