Structured Review: To Optimise Management and Prevent Harm in COPD

Sponsor
Northumbria Healthcare NHS Foundation Trust
Study ID
NCT07460154
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 10, 2026
Start date
Mar 11, 2026
Status verified
Jun 2025
Primary completion
Mar 2, 2029
Completion
Mar 2, 2029

Study Design

Enrollment
96 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Structured Health Assessment
    Structured 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

Primary Outcome Measure

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). [ Time Frame: 12 months (commencing 8 weeks after structured assessment complete). Measured at 5, 8, 11 and 14 months from enrolment. ]

Central Contacts

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