A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol.

Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF. The trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial. Yorkshire and The Humber - Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.

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Copyright ©ERS 2019.

Déclaration de conflit d'intérêts

Conflict of interest: C. Wright reports grants from the NIHR during the conduct of the study. Conflict of interest: S.P. Hart reports grants from the NIHR during the conduct of the study; and grants, personal fees and nonfinancial support from Boehringer Ingelheim outside the submitted work. Conflict of interest: V. Allgar reports grants from the NIHR during the conduct of the study. Conflict of interest: A. English reports grants from the NIHR during the conduct of the study. Conflict of interest: F. Swan reports grants from the NIHR during the conduct of the study. Conflict of interest: J. Dyson reports grants from the NIHR during the conduct of the study. Conflict of interest: G. Richardson reports grants from the NIHR during the conduct of the study. Conflict of interest: M. Twiddy reports grants from the NIHR during the conduct of the study. Conflict of interest: J. Cohen reports grants from the NIHR during the conduct of the study. Conflict of interest: J. Hussain reports grants from the NIHR during the conduct of the study. Conflict of interest: M. Johnson reports grants from the NIHR during the conduct of the study. Conflict of interest: I. Hargreaves reports grants from the NIHR during the conduct of the study. Conflict of interest: M.G. Crooks reports grants from the NIHR during the conduct of the study.