103326Development of technology to support the advance of new protease therapeuticsClosedFeasibility StudiesInnovate UKNeutrophil Elastase (NE) activity is associated with the severity of respiratory diseases including Cystic Fibrosis (CF) Chronic Obstructive Pulmonary Disease (COPD) and bronchiectasis. In these diseases repeated cycles of infection and inflammation result in the release of NE which causes lung damage. NE is predictive of loss of lung function and is the most informative biomarker of disease activity. NE inhibitors being developed by pharmaceutical companies as therapeutic drugs need to have their efficacy assessed within clinical samples from patients with respiratory disease. However, some adults, both from healthy and disease populations, alongside infants and young children, are unable to produce sputum. As a consequence, they are excluded from clinical trials involving these novel anti-NE therapies, that could otherwise prove beneficial. The challenge is to develop methods of measuring active NE from other biological fluids in the patients that would result in their inclusion in clinical trials. We have already commercialised an activity-based immunoassay which specifically measures active NE in sputum. This project aims to adopt this assay to be used with nasal fluid and breath condensate, which are easier to collect from most patients.