BronchUK: protocol for an observational cohort study and biobank in bronchiectasis.

Bronchiectasis has been a largely overlooked disease area in respiratory medicine. This is reflected by a shortage of large-scale studies and lack of approved therapies, in turn leading to a variation of treatment across centres. BronchUK (Bronchiectasis Observational Cohort and Biobank UK) is a multicentre, prospective, observational cohort study working collaboratively with the European Multicentre Bronchiectasis Audit and Research Collaboration project. The inclusion criteria for patients entering the study are a clinical history consistent with bronchiectasis and computed tomography demonstrating bronchiectasis. Main exclusion criteria are 1) patients unable to provide informed consent, 2) bronchiectasis due to known cystic fibrosis or where bronchiectasis is not the main or co-dominant respiratory disease, 3) age <18 years, and 4) prior lung transplantation for bronchiectasis. The study is aligned to standard UK National Health Service (NHS) practice with an aim to recruit a minimum of 1500 patients from across at least nine secondary care centres. Patient data collected at baseline includes demographics, aetiology testing, comorbidities, lung function, radiology, treatments, microbiology and quality of life. Patients are followed up annually for a maximum of 5 years and, where able, blood and/or sputa samples are collected and stored in a central biobank. BronchUK aims to collect robust longitudinal data that can be used for analysis into current NHS practice and patient outcomes, and to become an integral resource to better inform future interventional studies in bronchiectasis.

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Copyright ©The authors 2021.

Déclaration de conflit d'intérêts

Conflict of interest: A. De Soyza has received grants or personal fees from AstraZeneca, Bayer, Chiesi, Grifols, GSK, Pfizer and Novartis. Conflict of interest: P. Mawson has nothing to disclose. Conflict of interest: A.T. Hill has nothing to disclose. Conflict of interest: J.S. Elborn reports acting as chief investigator on a phase I programme for Ionis; involvement in an Innovative Medicines Initiative inhaled antibiotics in bronchiectasis and cystic fibrosis programme with Novartis, Polphor and Alaxia for the European Commission; and support received from Vertex for other projects and travel support to attend the Australian CF conference, all during the conduct of the study. Conflict of interest: J.M. Bradley has nothing to disclose. Conflict of interest: C.S. Haworth reports personal fees from Aradigm related to the Orbit studies; advisory board fees from Chiesi and Gilead; personal fees from Grifols related to the Orbit studies; advisory board fees from GlaxoSmithKline; personal fees from Novartis related to the iBEST studies; advisory board and speaker fees from Vertex; personal fees related to the Promis studies and advisory board fees from Zambon; educational grants, speaker fees and advisory board fees from Insmed Incorporated; a research grant and advisory board fees from International Biophysics; educational grants and speaker fees from Teva; consultancy fees from Meiji; advisory board fees from Janssen; and speakers fees from Mylan, all outside the submitted work. Conflict of interest: R.A. Floto has nothing to disclose. Conflict of interest: R. Wilson has nothing to disclose. Conflict of interest: M.R. Loebinger reports advisory board and lecture fees from Insmed and Grifols, and advisory board fees from Bayer, Polyphor and AstraZeneca, outside the submitted work. Conflict of interest: M. Carroll has nothing to disclose. Conflict of interest: M. Crichton reports personal fees from AstraZeneca outside the submitted work. Conflict of interest: J.D. Chalmers reports grants and personal fees from AstraZeneca and Boehringer Ingelheim, personal fees from Chiesi, grants and personal fees from GlaxoSmithKline, grants from Gilead Sciences, grants and personal fees from Insmed, and personal fees from Novartis and Zambon, outside the submitted work. Conflict of interest: A. Sullivan reports acting as a principal investigator for a multicentre Clinical Trial of Investigational Medicinal Product (CTIMP) sponsored by Novartis, and for a multicentre CTIMP sponsored by the University of Belfast with some medication/equipment provided by Pari Medical, both outside the submitted work. Conflict of interest: J. Brown has nothing to disclose. Conflict of interest: J.R. Hurst reports support to attend meetings, and payment to him and to his employer (University College London) for educational and advisory work from pharmaceutical companies that make medicines to treat respiratory diseases including bronchiectasis, outside the submitted work. Conflict of interest: J. Duckers has nothing to disclose. Conflict of interest: M. Kelly reports personal fees and nonfinancial support for presentations delivered locally from GlaxoSmithKline, and sponsorship to attend conferences from Bristol Myers Squibb and Napp, all outside the submitted work. Conflict of interest: J. Steer has nothing to disclose. Conflict of interest: T. Gatheral has nothing to disclose. Conflict of interest: P.P. Walker has nothing to disclose. Conflict of interest: C. Winstanley has nothing to disclose. Conflict of interest: A. McGuire has nothing to disclose. Conflict of interest: D. Denning and family hold founder shares in F2G Ltd, a University of Manchester spin-out antifungal discovery company. He acts or has recently acted as a consultant to Scynexis, Mayne, Pulmatrix, Pulmocide, Zambon, Biosergen and Fujifilm. In the last 3 years, he has been paid for talks on behalf of Hikma, Gilead and Pfizer. He is a longstanding member of the Infectious Disease Society of America Aspergillosis Guidelines group, the European Society for Clinical Microbiology and Infectious Diseases Aspergillosis Guidelines group, and the British Society for Medical Mycology Standards of Care committee. Conflict of interest: R. McNally reports that he is a coinvestigator on the MRC grant for the current study.