Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation: a mixed-methods feasibility randomised control trial

TY - JOUR

T1 - Home high-flow therapy during recovery from severe chronic obstructive pulmonary disease (COPD) exacerbation

T2 - a mixed-methods feasibility randomised control trial

AU - D'Cruz, Rebecca F

AU - Rossel, Anne

AU - Kaltsakas, Georgios

AU - Suh, Eui-Sik

AU - Douiri, Abdel

AU - Rose, Louise

AU - Murphy, Patrick B

AU - Hart, Nicholas

N1 - © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.

PY - 2025/1/6

Y1 - 2025/1/6

N2 - Introduction Patients recovering from severe acute exacerbations of chronic obstructive pulmonary disease (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, 30 L/ 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 (CAT), Clinical COPD Questionnaire), pulse oximetry, spirometry and inspiratory capacity, parasternal electromyography and actigraphy. Semistructured interviews were conducted in week 4. Trial progression criteria were: ≥40% of eligible patients randomised, ≤20% attrition, ≥70% complete data, and no device-related serious adverse events (SAE). Results 18 of 45 eligible patients were randomised (age 69±5 years, 44% female, body mass index 23±5 kg/ m 2, forced expiratory volume in 1 second 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 (CAT 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 (HFT) on admission-free survival in COPD patients recovering from a severe exacerbation.

AB - Introduction Patients recovering from severe acute exacerbations of chronic obstructive pulmonary disease (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, 30 L/ 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 (CAT), Clinical COPD Questionnaire), pulse oximetry, spirometry and inspiratory capacity, parasternal electromyography and actigraphy. Semistructured interviews were conducted in week 4. Trial progression criteria were: ≥40% of eligible patients randomised, ≤20% attrition, ≥70% complete data, and no device-related serious adverse events (SAE). Results 18 of 45 eligible patients were randomised (age 69±5 years, 44% female, body mass index 23±5 kg/ m 2, forced expiratory volume in 1 second 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 (CAT 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 (HFT) on admission-free survival in COPD patients recovering from a severe exacerbation.

KW - Humans

KW - Pulmonary Disease, Chronic Obstructive/therapy

KW - Female

KW - Male

KW - Aged

KW - Feasibility Studies

KW - Quality of Life

KW - Disease Progression

KW - Middle Aged

KW - Oxygen Inhalation Therapy/methods

KW - Treatment Outcome

KW - Home Care Services

KW - Severity of Illness Index

UR - http://www.scopus.com/inward/record.url?scp=85214537012&partnerID=8YFLogxK

U2 - 10.1136/bmjresp-2024-002698

DO - 10.1136/bmjresp-2024-002698

M3 - Article

C2 - 39762067

SN - 2052-4439

VL - 12

JO - BMJ Open Respiratory Research

JF - BMJ Open Respiratory Research

IS - 1

M1 - e002698

ER -