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Recruiting Not applicable NCT07460154

Structured Review: To Optimise Management and Prevent Harm in COPD

No applicable phase (e.g. observational)
Conditions: COPD

Sponsor: Northumbria Healthcare NHS Foundation Trust

trial.available_in: БГ
Overview
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.
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 n
Who can participate
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
Interventions
Sputum sample
DIAGNOSTIC_TEST
Venepuncture
DIAGNOSTIC_TEST
Lung function test
DIAGNOSTIC_TEST
Medical history and physical examination
DIAGNOSTIC_TEST
Blood pressure
DIAGNOSTIC_TEST
BMI
DIAGNOSTIC_TEST
HRCT of chest
RADIATION
ECG
DIAGNOSTIC_TEST
Echo
DIAGNOSTIC_TEST
Subject Questionnaires
DIAGNOSTIC_TEST
Research Questionnaires
DIAGNOSTIC_TEST
Influenza Vaccines
BIOLOGICAL
Pneumococcal Vaccine
BIOLOGICAL
RSV F vaccine (0.5mL injection)
BIOLOGICAL
Oxygen saturation (+/- ABG)
DIAGNOSTIC_TEST
DXA
RADIATION
Education
BEHAVIORAL
Locations 1
United Kingdom (1)
Northumbria NHS Foundation Trust
North Shields
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
35 Years
Healthy volunteers
No
Start date
11.03.2026
Completion date
02.03.2029
Registry ID
NCT07460154
Source
clinicaltrials.gov
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