Structured review to improve care and prevent harm for people with COPD
Official title: A Structured Health Assessment in Frequent COPD Exacerbators: To Optimise Management, Identify Comorbidities and Prevent Oral Corticosteroid Related Harm
Run by Northumbria Healthcare NHS Foundation Trust · NCT07460154 · Data updated 2026-11-12
This tests whether a detailed, structured review using sputum, blood and lung tests can reduce flare-ups and unnecessary steroid use in people with COPD who had three or more steroid prescriptions last year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Northumbria Healthcare NHS Foundation Trust Academic / other |
| Locations | 1 site (North Shields) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | March 2, 2029 |
| Study ends | March 2, 2029 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07460154 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 35 or older with a documented COPD diagnosis for at least 12 months who have had three or more separate prednisolone prescriptions in the past 12 months and are clinically stable and able to consent.
✕Probably not a fit
Patients on current or recent maintenance oral corticosteroids, those who are housebound, have a life expectancy under 12 months (other than COPD), have had a lung transplant, or use domiciliary non-invasive ventilation are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial delivers a complex, structured clinical review for people with COPD who frequently receive prednisolone, including sputum sampling, blood tests, lung function, blood pressure checks and a focused history and examination to identify misdiagnosis, comorbidities and treatable traits. Participants are adults with a documented COPD diagnosis for at least 12 months and at least three prednisolone courses in the prior year, and must be clinically stable at entry. The intervention aims to optimise management and avoid harm from repeated steroid exposure by identifying alternative causes of symptoms and unmet treatment needs. The trial is run at Northumbria NHS Foundation Trust with collaboration from AstraZeneca and compares this structured approach to usual care pathways.
Why it matters
Potential benefit: If successful, the approach could lower exacerbation frequency and reduce inappropriate steroid use and hospital admissions by identifying treatable conditions and optimizing therapy.
How similar studies have gone: Previous trials of targeted, multifaceted COPD management and comprehensive reviews have shown some reductions in exacerbations and hospital use, but applying a formal 'treatable traits' structured review to high-frequency steroid users is a relatively new approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. COPD diagnosis documented in primary care records for at least 12 months. 2. Age 35 years or older 3. 3 or more prednisolone prescriptions in the past 12-months for ECOPD\* 4. Capacity to give informed consent 5. Clinically stable at study entry (≥4 weeks following last ECOPD or other significant acute illness) \* each prednisolone course separated by a minimum of 14 days from completion of the previous course. Exclusion Criteria 1. Maintenance OCS use currently or within the past 12 months \* 2. Anticipated inability to comply with the protocol 3. Illness limiting life expectancy to less than 12 months (other than COPD) 4. Housebound 5. Lung transplant 6. Domiciliary non-invasive ventilation \*defined as ≥10mg daily for ≥ 6 weeks
Where it's running
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Northumbria NHS Foundation Trust
North Shields, United Kingdom Recruiting
Study contacts
- Principal investigator: Ruth E Sobala, MBBS — Northumbria Healthcare Foundation NHS Trust
- Study coordinator: Ruth E Sobala, MBBS
- Email: ruth.sobala2@northumbria-healthcare.nhs.uk
- Phone: +44191 293 4351
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.