# Complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): a feasibility, wait-list design randomised controlled trial

## TL;DR

This study tested a breathlessness intervention for people with lung diseases like IPF and found it feasible and potentially effective.

## Contribution

The study introduces a complex breathlessness intervention and demonstrates its feasibility for future trials in fibrotic lung disease patients.

## Key findings

- The recruitment rate was 2.5 participants per month across three sites.
- The intervention showed preliminary effectiveness in reducing breathlessness distress.
- Qualitative feedback confirmed the intervention's acceptability and feasibility.

## Abstract

Breathlessness is common and impairs the quality of life of people with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrotic interstitial lung diseases (ILD). We report the findings of a multicentre, fast-track (wait-list), mixed-methods, randomised controlled, feasibility study of a complex breathlessness intervention in breathless IPF and non-IPF fibrotic ILD patients.

Breathless IPF and non-IPF fibrotic ILD patients were randomised to receive the intervention within 1 week (fast-track) or after 8 weeks (wait-list). The intervention comprised two face-to-face and one telephone appointment during a 3-week period covering breathing control, handheld fan-use, pacing and breathlessness management techniques, and techniques to manage anxiety. Feasibility and clinical outcomes were assessed to inform progression to, and optimal design for, a definitive trial. A qualitative substudy explored barriers and facilitators to trial and intervention delivery.

47 patients (M:F 38:9, mean (SD) age 73.9 (7.2)) were randomised with a recruitment rate of 2.5 participants per month across three sites. The adjusted mean differences (95% CI) for key clinical outcomes at 4 weeks post randomisation were as follows: Chronic Respiratory Questionnaire breathlessness mastery domain (0.45 (−0.07, 0.97)); and numerical rating scales for ‘worst’ (−0.93 (−1.95, 0.10)), ‘best’ (−0.19 (−1.38, 1.00)), ‘distress caused by’ (−1.84 (−3.29, –0.39)) and ‘ability to cope with’ (0.71 (−0.57, 1.99)) breathlessness within the past 24 hours. The qualitative substudy confirmed intervention acceptability and informed feasibility and acceptability of study outcome measures.

A definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness.

ISRCTN13784514.