Exacerbation prevention in patients with both chronic obstructive pulmonary disease and obstructive sleep apnoea

Exacerbation prevention in chronic obstructive pulmonary disease (COPD) – obstructive sleep apnoea (OSA) overlap syndrome: The clinical and health economic impact of treating patients with COPD-OSA overlap syndrome and a high risk of future exacerbations with positive airway pressure therapy (PAP) a multicentre randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13475234

Enrollment

600

Registered

2025-01-20

Start date

2025-03-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Respiratory

Interventions

This is a multi-centre randomised controlled trial in patients with COPD-OSA overlap and a high risk of exacerbations. Participants will be randomised via a web-based, pre-programmed randomisation sys

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Moderate-severe COPD (GOLD grade 2-4) 2. High risk of future exacerbations: 1 severe (hospital assessed) exacerbation or 2 moderate (community clinician assessed) in the last 12 months 3. Moderate-severe OSA (AHI = = 15/h)

Exclusion criteria

Exclusion criteria: 1. Clinically significant or severe daytime sleepiness: Epworth Sleepiness score > 15 or excessive sleepiness likely to impair safe driving in current drivers (as evidence has already established that such patients should be treated with PAP therapy) 2. Significant hypercapnic respiratory failure at baseline assessment (PaCO2 > 6kPa, with evidence already indicating these patients should be treated with NIV) 3. PAP therapy mandated by the treating clinician due to the severity of the sleep symptom burden 4. Professional driver or other vigilance essential role with significant daytime sleepiness 5. Currently enrolled in an interventional clinical trial

Design outcomes

Primary

Measure	Time frame
Exacerbation frequency measured using exacerbation frequency 12 months post-randomisation data collected by the hospital, community and self-treated at randomisation, baseline to 12 months	—

Secondary

Measure	Time frame
Secondary outcome measures 1. The impact of 12 months of PAP therapy on quality of Life measured using the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score, extended MRC-Dyspnoea (eMRCD) score and 5-level EQ-5D version (EQ-5D-5L) at randomisation, baseline and 12 months 2. The impact of 12 months of PAP therapy on patient-reported sleep quality and daytime sleepiness measured using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Score (ESS) at randomisation, baseline and 3 and 12 months 3. The impact of 12 months of PAP therapy on Lung Function measured using Spirometry at randomisation, baseline and 3 and 12 months 6. The dose-response relationship between hours of PAP use and primary and secondary outcomes measured using usage hours downloaded from the PAP device, exacerbation frequency, patient-reported questionnaires (CAT, EQ5D5L, eMRCD, ESS, PSQI), spirometry, and healthcare utilisation at randomisation, baseline and 3 and 12 months (intervention group only) 7. The cost-effectiveness of PAP treatment in patients with COPD-OSA overlap in the UK health system over 12 months measured using data collected regarding healthcare utilisation and EQ5D5L at randomisation, baseline and 12 months Exploratory To explore the relationship between primary outcome and health-related quality of life based on COPD clinical phenotypes the following outcome variables will be assessed using participant characteristics, primary and secondary outcomes (exacerbation frequency, patient-reported questionnaires (CAT, EQ5D5L, eMRCD, ESS, PSQI), spirometry, healthcare utilisation) at randomisation, baseline and 12 months: 1. Significant sleepiness (defined as an ESS>/= 11), 2. Poor Sleep quality (defined as PSQI >5) 3. GOLD ABE grouping 4. Eosinophilic COPD (yes/no) 5. Bronchitic COPD (yes/no)	—

Measure

Time frame

Secondary outcome measures 1. The impact of 12 months of PAP therapy on quality of Life measured using the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score, extended MRC-Dyspnoea (eMRCD) score and 5-level EQ-5D version (EQ-5D-5L) at randomisation, baseline and 12 months 2. The impact of 12 months of PAP therapy on patient-reported sleep quality and daytime sleepiness measured using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Score (ESS) at randomisation, baseline and 3 and 12 months 3. The impact of 12 months of PAP therapy on Lung Function measured using Spirometry at randomisation, baseline and 3 and 12 months 6. The dose-response relationship between hours of PAP use and primary and secondary outcomes measured using usage hours downloaded from the PAP device, exacerbation frequency, patient-reported questionnaires (CAT, EQ5D5L, eMRCD, ESS, PSQI), spirometry, and healthcare utilisation at randomisation, baseline and 3 and 12 months (intervention group only) 7. The cost-effectiveness of PAP treatment in patients with COPD-OSA overlap in the UK health system over 12 months measured using data collected regarding healthcare utilisation and EQ5D5L at randomisation, baseline and 12 months Exploratory To explore the relationship between primary outcome and health-related quality of life based on COPD clinical phenotypes the following outcome variables will be assessed using participant characteristics, primary and secondary outcomes (exacerbation frequency, patient-reported questionnaires (CAT, EQ5D5L, eMRCD, ESS, PSQI), spirometry, healthcare utilisation) at randomisation, baseline and 12 months: 1. Significant sleepiness (defined as an ESS>/= 11), 2. Poor Sleep quality (defined as PSQI >5) 3. GOLD ABE grouping 4. Eosinophilic COPD (yes/no) 5. Bronchitic COPD (yes/no)

—

Countries

England, United Kingdom

Contacts

Public ContactDavid Smith

epic-osa@ndm.ox.ac.uk+44 (0)1865 225205

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026