Actively Recruiting

Phase Not Applicable
Age: 35Years +
All Genders
NCT07460154

Structured Review: To Optimise Management and Prevent Harm in COPD

Led by Northumbria Healthcare NHS Foundation Trust · Updated on 2026-04-23

96

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

Sponsors

N

Northumbria Healthcare NHS Foundation Trust

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Structured Review: To Optimise Management and Prevent Harm in COPD

Who Can Participate

Age: 35Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • COPD diagnosis documented in primary care records for at least 12 months.
  • Age 35 years or older
  • Three or more prednisolone prescriptions in the past 12 months for COPD exacerbations, each separated by at least 14 days from the previous course.
  • Capacity to give informed consent
  • Clinically stable at study entry with at least 4 weeks since last COPD exacerbation or significant acute illness
Not Eligible

You will not qualify if you...

  • Current or recent (within past 12 months) use of maintenance oral corticosteroids
  • Inability to comply with the study protocol
  • Illness limiting life expectancy to less than 12 months (other than COPD)
  • Being housebound
  • Having had a lung transplant
  • Use of domiciliary non-invasive ventilation defined as 10mg daily or more for 6 weeks or longer

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Northumbria NHS Foundation Trust

North Shields, United Kingdom

Actively Recruiting

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Research Team

R

Ruth E Sobala, MBBS

CONTACT

S

Stephen C Bourke

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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