Chronic obstructive pulmonary disease (COPD) Respiratory
Conditions
Interventions
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, us
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
40 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month all-cause admission-free survival measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed at 30 days, 3 months, 6 months and 12 months: CLINICAL 1. Respiratory admissions rates 2. Exacerbation frequency and severity 3. Dose-response relationship between HFT adherence and primary and secondary outcomes 4. Time to progression to long-term oxygen therapy (LTOT) 5. Time of progression to hypercapnic respiratory failure 6. Respiratory-specific mortality. Respiratory cause will be based on formal medical certificate of cause of death. 7. All-cause mortality PATIENT-CENTRED 8. Chronic obstructive pulmonary disease assessment test (CAT) score 9. Extended MRC-Dyspnoea (eMRCD) score 10. Pittsburgh Sleep Quality Index 11. Sputum clearance visual analogue scale 12. Hospital anxiety and depression scale 13. Quality of life (EQ-5D-5L) HEALTH ECONOMIC 14. Healthcare resource use (COPD-related primary & secondary care contact) 15. Change in respiratory medications (inc rescue packs issued) 16. Associated cost change with the above healthcare utilisation PHYSIOLOGICAL 17. Short physical performance battery (SPPB: timed 5 sit-to-stand, 5-STS; 4m gait speed, 4mGS; standing balance score) 18. Forced expiratory volume in 1 second (FEV1) 19. Force vital capacity (FVC) 20. End expiratory Lung Volume (EELV) measured using inspiratory capacity (IC) 21. Arterial partial pressure of carbon dioxide (PaCO2) and arterial partial pressure of oxygen (PaO2) while breathing room air (selected sites) 22. Physical Activity (day, night, sleep) (selected sites) 23. Neural Respiratory Drive (NRD) measured by 2nd intercostal space parasternal electromyogram (EMG) (selected sites) 24. Expiratory Flow Limitation (EFL) measured using force oscillation technique (impedance and reactance) (selected sites) MECHANISTIC 25. Upper and lower airway cell counts and supernatants for measures of inflammatory cytokines, including TH1, TH2, anti-inflammatory (selected sites) 26. Whole blood for measures of inflammation, including flow cytometry and cell isolation (selected sites) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactGill Radcliffe
Outcome results
None listed