About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
COPD diagnosis documented in primary care records for at least 12 months.
Age 35 years or older
3 or more prednisolone prescriptions in the past 12-months for ECOPD*
Capacity to give informed consent
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Sputum sample
Diagnostic testSputum sample
Venepuncture
Diagnostic testFBC, Total IgE, Corrected Calcium, Vitamin D, Liver function test, Early morning cortisol, HbA1C, NT pro BNP, Lipid panel, U\&E
Lung function test
Diagnostic testSpirometry, FENO +/- Gas transfer, body plethysmography
Medical history and physical examination
Diagnostic testMedical history and physical examination
Blood pressure
Diagnostic testBlood pressure
BMI
Diagnostic testWeight and height Waste and hip circumference
HRCT of chest
RadiationHRCT of chest (Strat X protocol) with coronary artery caclium score
ECG
Diagnostic testElectrocardiogram
Echo
Diagnostic testEchocardiogram
Subject Questionnaires
Diagnostic testClinical questionnaires: ESS, FRAX score, QRISK4,
Research Questionnaires
Diagnostic testResearch questionnaires: eMRCD, SQRQ-C, EQ-5D-5L, HADS-A, HADS-D, Seven step inhaler technique, PIH scale
Influenza Vaccines
Biological/VaccineFor those eligible under usual standard of care
Pneumococcal Vaccine
Biological/VaccineFor those eligible under usual standard of care
RSV F vaccine (0.5mL injection)
Biological/VaccineFor those eligible under usual standard of care
Oxygen saturation (+/- ABG)
Diagnostic testResting oxygen saturation on room air (+/- ABG)
DXA
RadiationParticipants 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
BehavioralEducation on Inhaler Technique, Medication Adherence, Tobacco \& Substance Abuse, Physical Activity, and COPD Self Management
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Proportion of participants with confirmed COPD (based on spirometry and clinical assessment).
Distribution of COPD by severity, endotype and phenotype.
Proportion of participants receiving new or adjusted COPD-specific treatments.
Proportion of participants with each comorbidity, stratified by whether the condition was previously recognised or newly identified.
Sponsors and contacts
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Northumbria Healthcare NHS Foundation Trust
Lead sponsor
AstraZeneca
Collaborator