Structured Review: To Optimise Management and Prevent Harm in COPD
STOPMYCOPD
A Structured Health Assessment in Frequent COPD Exacerbators: To Optimise Management, Identify Comorbidities and Prevent Oral Corticosteroid Related Harm
2 other identifiers
interventional
96
1 country
1
Brief Summary
Background: Chronic obstructive pulmonary disease (COPD) is a serious lung condition and the third leading cause of death worldwide. People with COPD have sudden and distressing flare-ups (exacerbations). These can be triggered by infections or occur without a clear cause. Flare-ups often lead to hospital admission, can cause a lasting health decline, increase the risk of dying and are strongly liked to lower income. Sometimes, people are wrongly diagnosed with COPD, when they have a different health issue. Other diseases (like heart conditions) are common in people with COPD, and share similar symptoms. These have often not been diagnosed and worsening of these conditions can look like a flare-up of COPD, leading to incorrect treatment. Additionally, many people with COPD have not been offered appropriate treatments that would reduce their flare-up frequency. COPD flare-ups are treated with steroid tablets (prednisolone), and sometimes antibiotics. Frequent use of prednisolone causes side effects such as weight gain, bone thinning (osteoporosis) and diabetes. Reducing how often people with COPD have flare-ups can reduce these side effects. The investigators aim to reduce COPD flare-ups and prevent harm from prednisolone by improving the treatment of COPD, while also checking for other health conditions. The goal: In people with COPD, who take prednisolone for flare-ups (three of more times a year), the investigators want to see if a thorough assessment (that focuses on the treatment of COPD and diagnosis of other common health problems), reduces the number of flare-ups that need prednisolone over the next year. Design: Participants will attend a half-day hospital visit for a thorough check-up (a mini-MOT). The assessment includes a review by a doctor, questionnaires, blood tests, breathing tests, a scan of the chest (CT), and investigations on the heart. The investigators will make sure participants receive the correct treatment for their COPD. The assessment will focus on three areas: lung health, identifying and treating important health issues outside of the lungs (that may be contributing or causing symptoms similar to COPD) and supporting changes in behaviours that can improve lung health. These factors (whether in the lungs, body or related to lifestyle) are known as treatable traits. The investigators will also review participants prednisolone use and check for health problems that may have been caused by it. At the end of the assessment participants will be given a personalised treatment plan. Participants will be followed up for 12 months, at 3 month intervals. During this time they will collect information on the number of emergency hospital visits, serious heart-related events, steroid tablets taken for COPD flare-ups and any deaths. They will ask participants to complete short questionnaires about their health and wellbeing. Who provided advise on this study : Preventing COPD flare-ups is a top priority, identified by The James Lind Alliance (a national research priority setting partnership). This study was reviewed by the Northumbria Lung Research Patient Advisory Group (people living with COPD). They felt the study was well-designed and likely to make a meaningful difference. People with experience in research and COPD also gave feedback, and changes were made, such as reducing travel requirements, based on their views. The research team has successfully completed studies that have led to real improvement in COPD care, and are committed to ensuring this study has a similar positive impact. Sharing results: At the end of the study results will be shared with the public, study participants, healthcare workers, commissioners and guideline advisory groups. The findings will be shared on online platforms, present them at national/international conferences, and published in medical journals. The aim is to ensure findings improve clinical practice, policies and guidelines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
March 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 2, 2029
April 23, 2026
June 1, 2025
3 years
December 11, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative dose of oral prednisolone over 12-months*. * excluding short courses of prednisolone prescribed for conditions not related to airway exacerbations (e.g. anaphylaxis, inflammatory bowel disease, cutaneous skin disorders).
12 months (commencing 8 weeks after structured assessment complete). Measured at 5, 8, 11 and 14 months from enrolment.
Secondary Outcomes (23)
Proportion of participants with confirmed COPD (based on spirometry and clinical assessment).
From enrolment to end of structured assessment (week 1)
Distribution of COPD by severity, endotype and phenotype.
From enrolment to end of structured assessment (week 1)
Proportion of participants receiving new or adjusted COPD-specific treatments.
From enrolment to review of investigation outcomes and adherence (week 8)
Proportion of participants with each comorbidity, stratified by whether the condition was previously recognised or newly identified.
From enrolment to review of investigation outcomes and adherence (week 8)
Number of new treatments initiated (per participant), both overall and by specific therapy (class/ type), started as result of the multidimensional assessment
Last subject, 8 week review
- +18 more secondary outcomes
Study Arms (1)
Structured Health Assessment
ACTIVE COMPARATORStructured Health Assessment 1. Confirm (or exclude) the COPD diagnosis and measure study outcomes 2. Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits 3. Perform a comprehensive multi-morbidity assessment 4. Deliver targeted educational interventions
Interventions
FBC, Total IgE, Corrected Calcium, Vitamin D, Liver function test, Early morning cortisol, HbA1C, NT pro BNP, Lipid panel, U\&E
Spirometry, FENO +/- Gas transfer, body plethysmography
Medical history and physical examination
HRCT of chest (Strat X protocol) with coronary artery caclium score
For those eligible under usual standard of care
Resting oxygen saturation on room air (+/- ABG)
Participants with a high or intermediate FRAX® risk score, or those aged \>50 years with a history of fragility fractures, will be offered a dual-energy x-ray absorptiometry scan (DXA)
Education on Inhaler Technique, Medication Adherence, Tobacco \& Substance Abuse, Physical Activity, and COPD Self Management
Clinical questionnaires: ESS, FRAX score, QRISK4,
Research questionnaires: eMRCD, SQRQ-C, EQ-5D-5L, HADS-A, HADS-D, Seven step inhaler technique, PIH scale
For those eligible under usual standard of care
For those eligible under usual standard of care
Eligibility Criteria
You may qualify if:
- COPD diagnosis documented in primary care records for at least 12 months.
- Age 35 years or older
- or more prednisolone prescriptions in the past 12-months for ECOPD\*
- Capacity to give informed consent
- 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.
You may not qualify if:
- Maintenance OCS use currently or within the past 12 months \*
- Anticipated inability to comply with the protocol
- Illness limiting life expectancy to less than 12 months (other than COPD)
- Housebound
- Lung transplant
- Domiciliary non-invasive ventilation \*defined as ≥10mg daily for ≥ 6 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northumbria Healthcare NHS Foundation Trustlead
- AstraZenecacollaborator
Study Sites (1)
Northumbria NHS Foundation Trust
North Shields, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth E Sobala, MBBS
Northumbria Healthcare Foundation NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2025
First Posted
March 10, 2026
Study Start
March 11, 2026
Primary Completion (Estimated)
March 2, 2029
Study Completion (Estimated)
March 2, 2029
Last Updated
April 23, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share