Exacerbation prevention in COPD - effect of home high-flow therapy versus usual care on hospital readmission or death after an acute chronic obstructive pulmonary disease (COPD) exacerbation: a UK-based multicentre randomised clinical trial
Chronic obstructive pulmonary disease (COPD)
Participants will be randomised into two parallel arms. To minimise imbalance and allow for known prognostic factors for future exacerbations, randomisation with stratification will be implemented, using the stratification factors of long-term oxygen use prior to enrolment, sex at birth, age (65 years) and BMI (=/25 kg/m²). Participants will be randomised to the intervention or control arm. If randomised to the intervention arm participants will subsequently then be issued with an HFT device - high flow heated humidified device system. Patients randomised to the intervention will receive standard of care plus home high-flow therapy via the LUMIS-HFT device. They will be expected to use the device for approximately 8 hours per 24-hour period where possible for 12 months. The HFT will be titrated at all sites via a standardised protocol. Those in the control arm will continue to receive standard of care as per their local site, which is a best practice based on current BTS guidelines.
Current inclusion criteria as of 11/06/2025: 1. Severe exacerbation of COPD* 2. Age 40+ years 3. Diagnosis of COPD as defined by GOLD criteria 4. Smoking history of >10 pack years 5. Forced expiratory volume in 1 second (FEV1) <80% predicted 6. FEV1/FVC < 0.7** *Severity defined by admission to hospital (acute admissions unit or hospital ward) **post bronchodilator _____ Previous inclusion criteria: 1. Severe exacerbation of COPD* 2. Age 40-80 years 3. Diagnosis of COPD as defined by GOLD criteria 4. Smoking history of >10 pack years 5. Forced expiratory volume in 1 second (FEV1) <80% predicted 6. FEV1/FVC < 0.7** *Severity defined by admission to hospital (acute admissions unit or hospital ward) **post bronchodilator
1. Significant obesity (BMI >35kg/m²) 2. Clinically significant obstructive sleep apnoea syndrome requiring PAP therapy (see screening procedures for more detail) 3. Major non-COPD chronic co-morbidity that may significantly contribute to risk of readmission or death within 1 year 4. Home PAP or NIV therapy