COPE-WEL observational validation trial.
Research type
Research Study
Full title
COPE-WEL observational validation trial. COPD Exacerbation alert system With urinE anaLysis Clinical validation of the Headstart® Test system for early detection of exacerbations in moderate/severe COPD patients.
IRAS ID
266942
Contact name
Christopher Brightling
Contact email
Sponsor organisation
Mologic Ltd
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
Patients will be asked to collect and test a daily urine sample using a novel testing system (HeadStart Test system) in addition to answering questions abut their daily COPD symptoms for 6 months.
In summary, this study aims to validate a novel non-invasive point of care (near-patient) testing system, to allow people with COPD to detect pulmonary exacerbations by measuring urinary biomarkers. If successful, we hope that this will provide patients with an easy to use device, which will empower patients and their caregivers to treat exacerbations at an earlier stage, with potential health and economic benefits.Results Summary
: Chronic obstructive pulmonary disease (COPD) is a chronic lung disease characterised by persistent breathing difficulties due to airflow obstruction. The Headstart® Test System is a home-use device for COPD patients that allows them to spot early signs of an exacerbation and manage their treatment. An exacerbation is defined as a significant worsening of breathing symptoms that requires new medication or hospital admission.The Headstart® system consists of disposable lateral flow cassettes, a compact reader, and an algorithm to analyse five biomarkers in urine. The algorithm acts as the test's embedded decision-making tool by analysing the biomarker levels and calculating the overall risk of an exacerbation. A significant change in these biomarker levels from the patient's personal baseline suggests increased inflammation in the body, which acts as an early alarm of an exacerbation.
Patients use the Headstart® system daily, by collecting a urine sample, running it on the lateral flow test, and placing the test into the reader. Results are then displayed on a smartphone app within 10 minutes.
The aim of the COPEWel study was to collect sufficient data to confirm the accuracy of the Headstart algorithm and evaluate its ability to identify a COPD exacerbation before clinical confirmation (which is typically done by a medical professional). Over a 24-month period, from November 2019 to October 2021, 86 COPD patients were recruited from 14 UK primary care sites, including Albany House, The BoatHouse Surgery, The Family Practice, Eynsham Medical Group, Buckinghamshire, Windrush Medical Practice, Hywel Dda University Health Board, Lindum Medical Practice, St Bartholomews Medical Centre, Kilmeny Medical Practice, The Rotherham NHS Foundation Trust, The Snaith & Rawcliffe Medical Group and Whiteladies and Wokingham Medical Centre.
Of the 86 participants recruited, 24 experienced 31 clinically confirmed exacerbations (meaning the symptoms was confirmed by a clinician, who then prescribed treatment). Symptoms patients experienced during an exacerbation included an increase in cough, phlegm, and/or shortness of breath. The exacerbations were distributed as follows: 18 participants had 1 exacerbation, 5 had 2, and 1 participant had 3. The study included 49 males and 36 females, with a median age of 71 years. Participant demographics showed 82 identified as White Caucasian, 1 as Asian, and 2 as multiracial. Regarding smoking status, 52 participants were ex-smokers, 32 were current smokers, and 1 participant had never smoked.
The study closed in January 2022 due to COVID-19 restrictions and therefore, failure to recruit the target of 263 patients. As a result, there were too few participants to reliably assess how well the test performs. The algorithm also underperformed due to significant differences in exacerbation severity compared to the previous study where the data was used to train the algorithm. The previous study comprised 100 patients recruited from 2 secondary care settings. Contributing factors to the underperformance included recruitment of less severe primary care patients, lower viral exacerbations from COVID-19 shielding, and diagnoses made over the phone as opposed to in person. Nevertheless, the algorithm successfully detected all four exacerbations that led to hospitalisations early, proving its effectiveness in identifying severe exacerbations.
To enhance the algorithm, it was re-trained by combining data from COPEWel and the previous study used for training, aiming to improve its generalisability by including a range of exacerbation severities. This new dataset comprised 83 exacerbations, with 62 exacerbations used for training. The algorithm’s performance was then evaluated on 21 unseen exacerbations, achieving a sensitivity of 76% and specificity of 87%, along with a 13-day median advance warning.
Further retraining with additional data will be necessary to continue refining the algorithm. A larger trial, involving at least 250 exacerbations, is recommended to enhance the algorithm’s generalisability.
Although the study did not reach its original recruitment target, it still showed that home use of the Headstart® system by COPD patients is feasible and that the algorithm could successfully detect all four exacerbations that led to hospitalisation at an early stage, indicating its potential to identify more severe cases. The real‑world data collected in a primary care setting also provided valuable insights to refine and retrain the algorithm, supporting better performance in future use.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0519
Date of REC Opinion
16 Aug 2019
REC opinion
Favourable Opinion