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Clinical Trial Summary

This is a single-centre, prospective observational cohort study assessing the potential utility of the Owlstone Medical "Breath Biopsy" in early diagnosis of pulmonary infections in patients with cystic fibrosis (CF). In cystic fibrosis pulmonary infections occur frequently and are associated with decline in lung function and disease progression, therefore a cornerstone of CF management is early identification and treatment of infections. "Breath Biopsy" is a non-invasive novel technology that has been trialled extensively in diagnosis of a variety of medical conditions with promising results. The technology is based the identification of a unique profile of organic compounds in exhaled breath of patients with a certain medical condition. Making the diagnosis of pulmonary infections in patients with CF is clinically challenging and at present relies on imprecise diagnostic tests, and generally requires attendance of patients to hospital or clinic for assessment. Ultimately, this research aims to assess the feasibility of incorporating "Breath Biopsy" into this diagnostic pathway with the advantages of both improving diagnostic certainty and potentially allowing in-home diagnosis of infections related to CF. Furthermore, identification of organic compounds implicated in CF infections will improve the understanding of why these infections occur, which to date remains an area that is poorly understood. Five patients with CF-related pulmonary infections admitted to the inpatient CF unit at the Royal Papworth Hospital will be enrolled, and use "Breath Biopsy" devices provided by Owlstone medical to collect breath samples from these patients in order to determine whether a unique organic compound profile can be identified in CF exacerbations.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05944367
Study type Observational
Source Papworth Hospital NHS Foundation Trust
Contact
Status Completed
Phase
Start date October 13, 2021
Completion date December 23, 2022

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