Abstract

Introduction
Patients recovering from severe acute exacerbations of COPD (AECOPD) have a 30-day readmission rate of 20%. This study evaluated the feasibility of conducting a randomised controlled trial to evaluate clinical, patient-reported and physiological effects of home high-flow therapy (HFT) in addition to usual medical therapy, in eucapnic patients recovering from AECOPD to support the design of a Phase 3 trial.

Methods
A mixed-methods feasibility randomised controlled trial (quantitative primacy, concurrently embedded qualitative evaluation) (ISRCTN15949009) recruiting consecutive non-obese patients hospitalised with AECOPD not requiring acute non-invasive ventilation. Participants were randomised to receive usual care or usual care and home HFT (37°C, 30L/min.) with weekly home-based follow-up for 4 weeks to collect data on: device usage, breathlessness (modified Borg scale, visual analogue scale, Multidimensional Dyspnoea Profile), health-related quality of life (COPD Assessment Test, Clinical COPD questionnaire), pulse oximetry, spirometry and inspiratory capacity, parasternal electromyography and actigraphy. Semi-structured interviews were conducted in week 4. Trial progression criteria were: ≥40% of eligible patients randomised, ≤20% attrition, ≥70% complete data, no device-related serious adverse events (SAE).
Results 18 of 45 eligible patients were randomised (age 69±5 years, 44% female, BMI 23±5kg/m2, FEV1 32±12%). One withdrew following non-respiratory hospitalisation. Complete outcome measures were collected in >90% of home assessments. There were no device-related SAE. Daily HFT usage was 2.7±2.2 hours in week 1, falling to 2.3±1.4 hours by week 4. Temperature and flow settings were modified for comfort in 6 cases. Higher HFT usage was associated with lower symptom burden (COPD assessment test p=0.01). Interviews highlighted ease of device use, reduced salbutamol usage, and improved sputum production and clearance.

Conclusions
The data from this feasibility study support the progression to a Phase 3 randomised clinical trial investigating the effect of home high-flow therapy on admission-free survival in COPD patients recovering from a severe exacerbation. 

What is already known on this topic: High-flow therapy (HFT) delivers heated humidified gas (air with or without oxygen enrichment) to the airways. Preliminary data in clinically stable patients with COPD and chronic respiratory failure indicates possible clinical benefits including reduced exacerbation rates and breathlessness and improved gas exchange and exercise capacity. Patients hospitalised with severe COPD exacerbation even without comorbid respiratory failure are at high-risk of re-exacerbation and readmission despite pharmacological optimisation and pulmonary rehabilitation.
What this study adds: Home HFT is safe and acceptable to patients to patients recovering from severe COPD exacerbation, and it is feasible to conduct a Phase 3 randomised clinical trial evaluating the effect of home HFT on admission-free survival.

How this study might affect research, practice or policy: This study informs the design of a UK Phase 3 clinical trial to investigate whether home HFT is an effective adjunct to reduce re-admission and mortality in patients recovering from severe COPD exacerbation.

Original languageEnglish
JournalBMJ Open Respiratory Research
Publication statusAccepted/In press - 5 Dec 2024

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