Abstract
Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
Abstract
Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease. This study protocol describes the BREEZE-IPF study: a feasibility, randomised controlled trial of a holistic, complex breathlessness intervention in IPF. http://bit.ly/33eF9im
Footnotes
This study is registered at the ISRCTN registry with identifier number ISRCTN13784514. The investigators will agree a data management and access plan with the funder, the National Institute of Health Research, prior to completion of data collection. Anonymised data will be deposited in a discoverable data registry following publication of the primary study outputs. A study data access committee will review requests to access data and will require a data use agreement to be signed. The data use agreement will detail the agreed use and appropriate management of the research data to be shared, and include a requirement for recognition of the contribution of the researchers who generated the data and the original funder.
Author contributions: M.G. Crooks, V. Allgar, A. English, S.P. Hart, F. Swan, J. Dyson, M. Johnson, J. Hussain, G. Richardson, M. Twiddy and J. Cohen are coapplicants on the grant. M.G. Crooks, V. Allgar, A. English, S.P. Hart, F. Swan, J. Dyson, M. Johnson, G. Richardson, M. Twiddy, J. Cohen, I. Hargreaves and C. Wright assisted in development of the protocol and implementation of the study. M.G. Crooks, C. Wright and J. Cohen drafted the manuscript. All authors read and approved the final manuscript.
Support statement: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Programme (PB-PG-1216-20020). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Dept of Health and Social Care. Funding information for this article has been deposited with the Crossref Funder Registry.
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.
- Received July 26, 2019.
- Accepted July 27, 2019.
- Copyright ©ERS 2019
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