About the project
Title: BREEZE 2: A randomised controlled trial of a complex intervention to manage breathlessness in pulmonary fibrosis
Funder: NIHR Research for Patient Benefit
Time frame: 2024 - 2026
Contact for more details: Professor Michael Crooks (Clinical Sciences Centre) and Dr Ann Hutchinson
Diseases which cause scarring of the lungs (called pulmonary fibrosis) usually affect older adults. They progress over time, causing regular coughing and making it hard to breathe. There are medications that slow disease progress, however they do not improve symptoms nor quality of life.
Shortness of breath is the most common symptom and the one which has the biggest impact on the lives of those affected. Breathlessness treatments work for people with other lung conditions, but we do not know whether they work for people with lung scarring.
It is important that we find out how to help people affected, doctors and policy makers make correct treatment decisions. To be able to know if breathlessness management helps people with pulmonary fibrosis we first needed to find out the best way to design a full trial, so we carried out the BREEZE feasibility study.
We wanted to understand how many patients will be suitable and willing to take part in a trial of a breathlessness treatment, how many would complete the study tests and which measurements are most meaningful.
Forty-seven breathless patients with pulmonary fibrosis were randomly selected to receive the breathlessness treatment straight away or to wait eight weeks before starting the treatment.
The treatment involved training in techniques to help breathlessness and was delivered during two appointments and a telephone call over three weeks. Breathlessness and quality of life assessments and daily activity measurements were performed at the start of the study and repeated every four weeks for 16 weeks.
The pre-agreed criteria to decide if it is possible to do a larger trial to test the breathlessness treatments effectiveness were all met. This means that the overall design of the study can remain the same with only minor changes to ensure the success of the full trial.
Although the BREEZE study was not designed to test the treatment’s effectiveness, patients that received the treatment straight away appeared to improve across a range of breathlessness measures compared with those waiting for the treatment. This strongly supports the need for a larger trial.
Patients and the public have been involved in this research from the beginning. Members of the Hull pulmonary fibrosis support group consider this is an important area of research, as do Action for Pulmonary Fibrosis and Asthma and Lung UK.
We are now organising a full trial, called BREEZE 2, to find out if the breathlessness treatment works for people with pulmonary fibrosis and if it is affordable to the NHS.
Outputs
Wright C, Hart SP, Allgar V, et al. A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol. ERJ Open Res 2019; 5: 00186-2019 [https://doi.org/10.1183/23120541.00186-2019]