Lung Clearance Index (LCI) as a Sensitive measure of Early Airway Change in Cystic Fibrosis.
University Hospital of South Manchester
Cystic fibrosis (CF) is an inherited condition characterised by chronic lung infection and progressive fall in lung function that starts in infancy. The current standard for assessing lung function is spirometry, though this is insensitive to early disease and is difficult for many patients (especially the young) to perform. There thus exists in children and young adults a gap in our ability to assess lung function at precisely the stage when interventions (such as treatment to eradicate new infections) are most likely to be of benefit and when there is most to gain. Recent research has shown that a new breathing test is better at detecting early changes in the CF lung and responds better to treatments. The test involves relaxed breathing during which the wash-out of a harmless tracer gas from the lungs is followed to produce the lung clearance index (LCI), a simple non-invasive measure of the efficiency of gas mixing in the lungs. LCI has now been measured in hundreds of CF patients, including infants, and its value in research is well recognised. We want to use this test in clinical practice to see whether it will identify important changes in health before our current methods (spirometry, symptoms). To do this, we will use a recently-evaluated and improved system that is portable and quicker to use in a multicentre study of 70 patients and 60 controls across two sites in Manchester (RMCH and UHSM). We will collect clinical information recorded during outpatient visits on a standardised report form. We will also collect sputum results, and additional sputum if possible, so that we can investigate the ability of the test to detect changes caused by new infections. For CF patients, LCI will be repeated at each outpatient visit for up to 3 years.
North West - Preston Research Ethics Committee
Date of REC Opinion
18 Sep 2014