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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Diagnostic test: ECG; Diagnostic test: Sputum sample; Diagnostic test: Venepuncture; Diagnostic test: Lung function test; Diagnostic test: Medical history and physical examination; Diagnostic test: Blood pressure; Diagnostic test: BMI; Radiation: HRCT of chest; Diagnostic test: Echo; Diagnostic test: Subject Questionnaires; Diagnostic test: Research Questionnaires; Biological: Influenza Vaccines; Biological: Pneumococcal Vaccine; Biological: RSV F vaccine (0.5mL injection); Diagnostic test: Oxygen saturation (+/- ABG); Radiation: DXA; Behavioral: Education

Detailed Description

Background:

Chronic obstructive pulmonary disease (COPD) is a serious lung condition and the third most common cause of death worldwide. In England, COPD causes 121,129 hospital stays and 20,000 deaths each year. Despite how common and serious it is, only 2% of public research funding targets lung diseases like COPD.

People with COPD have sudden and distressing flare-ups (exacerbations). These can be triggered by infections or occur without a clear cause. Exacerbations are serious, they often lead to hospital admission, can cause a lasting health decline, increase the risk of dying and are strongly liked to lower income.

Frequent exacerbators is a term used to describe people who experience 2 or more COPD exacerbations each year, and super-exacerbators have 3 or more exacerbations each year. COPD flare-ups are treated with steroid tablets (prednisolone) and sometimes antibiotics. Steroid tablets help recovery but frequent use causes side effects such as weight gain, bone thinning (osteoporosis) and diabetes. People with COPD receive steroids very frequently; a third of all UK steroid prescriptions are for people with COPD, and this number is increasing.

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.

Treatable traits are health-related factors (linked to the lungs, the body and lifestyle choices) that, when identified and managed, can help improve a person's health. Unfortunately many people who are at risk of frequent COPD flare ups are not getting the care they need. According to a 2024 survey by Asthma and Lung UK only 9% of people with COPD are receiving all the key parts of recommended care.

The primary aim of the study is to find out if a thorough health assessment, focused on improving participants COPD treatment and identifying other health problems (treatable traits, conditions caused by prednisolone and other common health conditions) will reduce the number of COPD flare-ups individuals have over the next year.

STOPmyCOPD focuses on a group of people who have very frequent COPD exacerbations. They are often from disadvantaged backgrounds, rely heavily on healthcare services, and experience worse health outcomes. There is a need to improve diagnoses and treatment in these patients.

What is STOPmyCOPD:

STOPmyCOPD is a research study looking at people with COPD, who take prednisolone (steroids) for flare-ups of their condition, 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 conditions), reduces the number of flare-ups that need prednisolone over the next year.

Secondary research questions:

1. How many people in the study have COPD and categorise participants by severity, the cause of their COPD, and key characteristics.
2. How many people start new treatments or have changes to their COPD treatment.
3. How many people are found to have a new health condition, and how many start or change treatment for the new health condition.
4. Find out how much steroid (prednisolone) people have taken in the last year and in the previous years.

Who has been involved:

STOPmyCOPD has been designed for patients and the wider NHS. It supports the goals of the North East and North Cumbria Integrate Care Board and directly addresses the top research priorities of the James Lind Alliance for managing COPD flare-ups (exacerbations).

1. Preventing exacerbations
2. Understanding how other health problems affect COPD exacerbations.
3. Looking at the pros and cons of 'rescue packs' (emergency medication packs containing prednisolone for people with COPD).

Seven people with confirmed COPD and a strong interest in research reviewed the study. They looked at how relevant it was, how practical it was and what challenges might occur. They felt STOPmyCOPD tackled an important issue and found the study design clear. Importantly they felt the number of clinic visits and tests were reasonable. One person raised a concern about travel time, so the assessment was amended to a half-day visit, reducing travel burden.

The Northumbria Lung Research Patient Advisory Group (PAG), a group of people with COPD also gave feedback. They felt a study of this type was urgently needed. They highlighted that the number of research trials for people with COPD is limited and that COPD research is underfunded. The PAG highlighted the importance of using easy to understand language in documents for patients. The group recommended having regular meetings every six months to stay involved in the study, and this has been built into the design.

The study design was developed with the help of Dr Nan Lin (Senior Lecturer in Biostatistics , Population Health Sciences Institute, Newcastle University). He is an expert in this type of research. It has additionally been reviewed by two independent experts in COPD and a Teaching and Research Fellowship committee reviewed the project as part of a Teaching and Research Fellowship. The study was reviewed by AstraZeneca as part of their externally sponsored scientific research (ESR). This underwent review by the Global Reviewing Committee and was endorsed to be scientifically and strategically valid. Consistent and extremely positive feedback was received from all reviewers.

The the host organisation has reviewed and fully endorsed the project.

Design:

The study uses a design where each person is compared to themselves over time (stepped wedge cluster randomisation study). This means the investigators will look at how often each participant had COPD flare-ups before and an intervention, rather than comparing them to other people. Adjustments for external factors (such as the prevalence of flu in the community at the time) will be made to ensure these factors do not affect the results.

The study requires 96 participants, with recruitment scheduled over 24 months. This value includes a margin of error in case some people leave the study early.

Recruitment:

Adults aged 35 and over, who have COPD and have taken three or more courses of prednisolone (in the past 12-months) to treat COPD flare-ups will be invited to patricipate. At the time of entering the study participants must not have had a flare up in the last four weeks.

People will not be able to take part if they take steroids tablets (prednisolone) every day for another health condition, have had a lung transplant, use a type of breathing support called NIV (non-invasive ventilation), are housebound or have a serious illness that means they spend most time at home or are unlikely to live beyond 12 months.

Participants will be identified through a number of different channels across the North East and North Cumbria Region:

• GP's will send out invitation letters and text messages.
• Patients admitted to the Northumbria Emergency Care Hospital with a COPD flare up will be invited.
• Pharmacists and/or nurses in General Practices will tell patients about the study during medication reviews.
• People who have already shown interest in research through registering on the 'Be Part of Research' platform will be invited to join.
• Digital adverts displayed in hospital waiting areas/ GP practices and on social media.
• VONNE (a network of voluntary organisations in the North East) will help by sharing information about the study with local groups. The Health and Race Equality Forum (HAREF) will support by including study information in their newsletter.
• A study website hosted by Northumbria NHS Foundation Trust will contain study details and contact information for the research team.

A member of the research team will contact eligible participants by telephone, letter or in person, once they have confirmed they are willing to be contacted. They will provide a patient information sheet, which participants can read themselves or have read aloud to them. Ample time will be given to review the information, ask questions and consider participation. Any questions will be answered by a trained member of the research team.

Participants will be reimbursed for travel and will also receive a £100 voucher at the end of the study as a thankyou.

Method:

The study involves a hospital visit, a follow up appointment, and four telephone calls. The first appointment is a hospital visit in which participants undergo the detailed health check. Following this there is one review appointment followed by four short telephone calls over the next year.

Before the Health Assessment Before the health assessment basic information from participants electronic health record will be collected. This will include demographics, past medical conditions and current medications.

The Detailed Health Assessment

The hospital visit will take around half a day. During this visit the study team will:

1. Confirm (or exclude) the diagnosis of COPD.
2. Make sure participants are on the right COPD treatment for them.
3. Look for other health issues that may be caused by prednisolone use, contribute to symptoms or increase flare-up frequency.
4. Look for common health conditions that have not yet been diagnosed.

d) Support behaviour changes that can improve lung health. e) Provide targeted education.

Participants will be seen by a doctor and asked to complete questionnaires about their health and quality of life. They will undergo the following investigations:

• Sputum sample
• Weight and height and waist circumference
• Blood pressure
• Oxygen levels
• Blood tests
• Breathing tests
• A scan (CT) of the lungs/chest
• Heart tests (an ECG and an echocardiogram)

Depending on these test results some participants may require further investigations These could include a more detailed scan of the heart (CT coronary angiogram), a bone scan (DEXA), a sleep study and additional blood tests (arterial blood gas). These tests will not be required in all participants and may be arranged to happen at a later date.

At the end of the assessment the study team will make sure participants are receiving the correct treatment for their COPD. If any new health conditions (comorbidities) are found, treatment (for example new medication) will be started and optimisation by the study team/or GP. Any treatment offered will follow national NHS guidance and be part of standard care. Participants GP will be kept fully informed of any new diagnoses or treatments.

Follow Up:

Eight weeks after the health assessment the study team will contact participants to discuss their results and any new diagnoses. The team will review whether any new treatments have been started and whether medication is being taken as prescribed.

Participants will then be followed up every 3 months for 12 months with short telephone assessments. During these encounters participants will complete questionnaires about their health and wellbeing. The study team will also collect information about them from their electronic health record, such as the number of emergency hospital visits, serious heart-related events, prednisolone courses taken for COPD flare-ups and deaths.

Timeline:

Recruitment is scheduled for March 2026, with results expected in 2029. There is a planned 24-month recruitment period, allowed the last participant 12 months to complete follow-up.

Sharing results:

This study targets a group of people who face significant health challenges and often have poor health outcomes. 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. To ensure results reach policymakers, the investigators will also engage with the British Thoracic Society COPD Specialist Advisory Group, NICE, and Asthma and Lung UK. The aim is to ensure findings improve clinical practice, policies and guidelines.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruth E Sobala, MBBS; Phone Number: +44191 293 4351; Email: ruth.sobala2@northumbria-healthcare.nhs.uk
• Study Contact Backup: Name: Stephen C Bourke; Phone Number: +44191 293 4351; Email: stephen.bourke@northumbria-healthcare.nhs.uk

Study Locations

• United Kingdom
  • North Shields, United Kingdom
    • Recruiting
    • Northumbria NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Structured Health Assessment; Structured Health Assessment; Confirm (or exclude) the COPD diagnosis and measure study outcomes; Identify and treat pulmonary, extra-pulmonary and modifiable behaviour traits; Perform a comprehensive multi-morbidity assessment; Deliver targeted educational interventions

Diagnostic test: ECG; Electrocardiogram; Diagnostic test: Sputum sample; Sputum sample; Diagnostic test: Venepuncture; FBC, Total IgE, Corrected Calcium, Vitamin D, Liver function test, Early morning cortisol, HbA1C, NT pro BNP, Lipid panel, U&E; Diagnostic test: Lung function test; Spirometry, FENO +/- Gas transfer, body plethysmography; Diagnostic test: Medical history and physical examination; Medical history and physical examination; Diagnostic test: Blood pressure; Blood pressure; Diagnostic test: BMI; Weight and height Waste and hip circumference; Radiation: HRCT of chest; HRCT of chest (Strat X protocol) with coronary artery caclium score; Diagnostic test: Echo; Echocardiogram; Diagnostic test: Subject Questionnaires; Clinical questionnaires: ESS, FRAX score, QRISK4,; Diagnostic test: Research Questionnaires; Research questionnaires: eMRCD, SQRQ-C, EQ-5D-5L, HADS-A, HADS-D, Seven step inhaler technique, PIH scale; Biological: Influenza Vaccines; For those eligible under usual standard of care; Biological: Pneumococcal Vaccine; For those eligible under usual standard of care; Biological: RSV F vaccine (0.5mL injection); For those eligible under usual standard of care; Diagnostic test: Oxygen saturation (+/- ABG); Resting oxygen saturation on room air (+/- ABG); Radiation: DXA; 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); Behavioral: Education; Education on Inhaler Technique, Medication Adherence, Tobacco & Substance Abuse, Physical Activity, and COPD Self Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total cumulative dose of oral prednisolone (per year) for the past 10 years (or since COPD diagnosis if more resent).	The cumulative dose of oral prednisolone (per year) for the past 10 years will be recorded, except for participants whose diagnosis is less than 10 years old and who therefore have not had the opportunity to receive prednisolone for the full 10-year period.	From enrolment to end of structured assessment (week 1)
Number of oral prednisolone courses (per year) over the past 10 years (or since COPD diagnosis if more resent).	The number of prescribed course of oral prednisolone (per year) for the past 10 years will be recorded, except for participants whose diagnosis is less than 10 years old and who therefore have not had the opportunity to receive prednisolone for the full 10-year period.	From enrolment to end of structured assessment (week 1)
Covariates independently associated with cumulative corticosteroid dose.	The dependent variable is total cumulative corticosteroid dose (measured in mg prednisolone over 12 months or equivalent if an alternative corticosteroid is administered). Multiple regression modelling will be used to identify demographic, physiological, clinical and psychological covariates independently associated with cumulative corticosteroid exposure. Effect estimates will be reported as regression coefficients with 95% confidence intervals. Key candidate varibles are lised below: Demographic:Age, Sex; Physiological:BMI (weight and height combined to BMI in kg/m^2), FEV1, FeNO, Blood eosinophils, Total IgE; Clinical:Change in primary diagnosis, phenotype, cumulative corticosteroid use 12 months prior to study entry, inpatient days over 12 months prior to study entry, maintenance inhaled therapy, azithromycin, biologic therapy, LTOT, comorbidities (previously recognised and new), eMRCD, pulmonary rehab within 12 months of study entry (prior or prospectively); HADS Score, SGRQ.	From visit 2: 8 weeks to end of study (14 months)
Mortality: all cause and respiratory.		14 months from enrolment. Measured at 5, 8, 11 and 14 months.
Non fatal and fatal major adverse cardiovascular events		14 months from enrolment. Measured at 5, 8, 11 and 14 months
Time to first cardiopulmonary event.		14 months from enrolment. Measured at 5, 8, 11 and 14 months
Time to death (all cause and respiratory).		14 months from enrolment. Measured at 5, 8, 11 and 14 months
12. Mean change in St George's Respiratory Questionnaire- COPD	Sum of maximum possible weights for each component and Total: Symptoms: 566.2 Activity: 982.9 Impacts: 1652.8 Total (sum of maximum for all three components) 3201.9 (Note: these are the maximum possible weights that could be obtained for the worst possible state of the patient).	14 months from enrolment. Measured at week 1, 5 months, 8 months, 11 months and 14 months.
12. Mean change in quality of life (EQ-5D-5L)	5 health states scored out of 5. Level 1: indicating no problem, Level 5: indicating unable to/extreme problems.	14 months from enrolment. Measured at week 1, 5 months, 8 months, 11 months and 14 months.
12. Mean change in quality of life (EQ VAS)	EQ VAS- total score 100. 100 is the best health, 0 the worst health.	14 months from enrolment. Measured at week 1, 5 months, 8 months, 11 months and 14 months.
Mean change in anxiety and depression (Hospital Anxiety and Depression Scale)	HADS A -21 points HADS D- 21 points 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)	14 months from enrolment. Measured at week 1 and 14 months.
Change in patient activation (Partners in health scale)	12 areas scored out of 9 (zero being the lowest response, reflecting low self-management capacity, and eight being the highest, reflecting good self-management capacity).	14 months from enrolment. Measured at week 1 and 14 months.
Number of moderate and severe exacerbations		14 months from enrolment. Measured at 5, 8, 11 and 14 months
Number of severe ECOPD (unplanned hospital admission) per annum.		14 months from enrolment. Measured at 5, 8, 11 and 14 months
Number of Emergency department visits per annum: all-cause and respiratory.		14 months from enrolment. Measured at 5, 8, 11 and 14 months
Inpatient hospital bed days per annum: all cause and respiratory.		14 months from enrolment. Measured at 5, 8, 11 and 14 months
Non fatal major adverse cardiovascular events per annum (nonfatal stroke, nonfatal myocardial infarction).		14 months from enrolment. Measured at 5, 8, 11 and 14 months
Total cumulative dose of oral prednisolone per year over the past 10 years (or since COPD diagnosis if more resent).		From enrolment to end of structured assessment (week 1)

Collaborators and Investigators

• Sponsor: Northumbria Healthcare NHS Foundation Trust
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Ruth E Sobala, MBBS, Northumbria Healthcare Foundation NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 2, 2029
• Study Completion (Estimated): March 2, 2029

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Steroid; Comorbidity; Complex Intervention; Structured assessment; Treatable Trait; Exaceration; Oral Corticosteroid; Multimorbity
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Drug Administration Routes; Drug Therapy; Circulatory and Respiratory Physiological Phenomena; Environment and Public Health; Physical Phenomena; Socioeconomic Factors; Population Characteristics; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Diagnostic Techniques, Respiratory System; Biological Products; Complex Mixtures; Diagnostic Techniques, Cardiovascular; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Heart Function Tests; Electrodiagnosis; Metabolism; Viral Vaccines; Blood Chemical Analysis; Clinical Chemistry Tests; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Geological Phenomena; Injections; Educational Status; Respiratory Function Tests; Pneumococcal Vaccines; Electrocardiography; Blood Gas Analysis; Blood Specimen Collection; Influenza Vaccines; Blood Pressure; Physical Examination; Oxygen Saturation; Caves
• Other Study ID Numbers: NHCT0594; ESR-25-22912 (Other Grant/Funding Number: AstraZeneca)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No