BREATHE: Bristol Airways Cohort

BREATHE is a single-centre, prospective longitudinal cohort study of patients who are referred to the Complex Airways Clinic at North Bristol NHS Trust (NBT). It is a platform which will include different sub-studies when they are developed in the future (with amendments reviewed by the sponsor and HRA at the time). BREATHE will record routinely collected clinical data at each stage of the multidisciplinary assessment, diagnosis and management of each patient from initial assessment until they are discharged by the service, or the study ends. The study will not include any additional investigations, questionnaires or patient visits which would not have been included as part of each patient’s routine clinical management. The landscape of airway disease management will change over the next 5 years. As such BREATHE will incorporate an adaptive study design. As novel diagnostics and therapeutics emerge, it is anticipated that changes will be made to standard care which would necessitate changes to the data that is collected. If substantial changes are made, they will be assessed for inclusion in the study and request further ethical approval if necessary. The BREATHE cohort is to be a source of potential subjects for future studies.