Predict and Prevent 

A phase III, 2 arm, multi-centre, open label, parallel-group randomised designed clinical investigation of the use of a personalised early warning decision support system with novel saliva bio-profiling to predict and prevent acute exacerbations of Chronic Obstructive Pulmonary Disease - 'Predict & Prevent AECOPD'

Important Message: COVID-19

We are now home-based during the COVID-19 pandemic but available and working. Responses may however take longer than normal as staff may be working altered hours but we are cross covering trials as required and urgent matters will be dealt with promptly. Please do not contact our usual office/landline number and instead email the trial contact and copy in the trial mailbox. If a query requires a prompt response please mark as ‘urgent’ in the email subject header.




Clinical investigation Design: A phase III, 2 arm, multi-centre, open label, parallel-group, individually randomised clinical investigation   

Objectives: Our overall ambition is clinical validation and commercialisation of the COPDPredictTM to guide and support chronic obstructive pulmonary disease (COPD) patients in identifying exacerbations early, leading to a reduction in total acute exacerbations of COPD (AECOPD)-induced hospital admissions in the 12 months following each patients randomisation. Using a multi-skills team approach, we aim to complete the trial over 27 months.

The aim is to assess:

1) The clinical-effectiveness of COPDPredictTM (with regard to hospitalisation rate over the course of a year)

2) The cost- effectiveness of COPDPredictTM (in terms of whether patients use more or less health resources to manage their COPD)  


Suitable patients will be identified at NHS Trusts across the Birmingham and Coventry UK.

Target Population

Participant Population and Sample Size: 384 adult COPD patients who have had ≥2 AECOPD or ≥1 hospital admission for AECOPD in the previous year


Control Arm: a standard self-management plan (SSMP) involving the use of rescue medication (RM) containing 5 days of antibiotic and steroid treatment 

Experimental Arm:  supported self-management using the COPDPredictTM App, involving personalised alerts to both patients and the clinical care team 

Measurement of outcomes

There are a large number of objectives for this study:

Primary Objectivces: The number of hospital admissions up to t 12 months post randomisation, where the primary reason for admission is AECOPD

Secondary Objectives:  Over a 12 month period, following randomisation

  1. Total inpatient days
  2. Number of patient defined exacerbations
  3. Number of visits to Accident and Emergency (A&E)
  4. Symptom control markers, specifically the amount of breathlessness 
  5. End-user experience (technology acceptability usability/utility via questionnaires and interviews)
  6. Health-related quality of life (COPD Assessment Test, CATTM and EQ-5D-5L)
  7. Lifestyle choices via App usage/questionnaires/interviews
  8. Blood C-Reactive Protein (CRP) levels 
  9. FEV1 at 12 months
  10. Social acceptability and practical responses to the intervention, including any implementation issues    

More information...

Funder- NIHR (National Institute for Health Research)