Phase III, two arm, multi-centre, open label, parallel-group randomised designed clinical investigation of the use of a personalised early warning decision support system to predict and prevent acute exacerbations of chronic obstructive pulmonary disease: ‘Predict & Prevent AECOPD’ – study protocol

Dalbir Kaur*, Rajnikant L Mehta, Hugh Jarrett, Sue Jowett, Nicola Gale, Alice Turner, Monica Spiteri, Neil Patel

*Corresponding author for this work

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Abstract

Introduction: With 65 million cases globally, chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death and imposes a heavy burden on patients’ lives and healthcare resources worldwide. Around half of all patients with COPD have frequent (≥2 per year) AECOPD5. Rapid readmissions are also common. Exacerbations impact significantly on COPD outcomes, causing significant lung function decline. Prompt exacerbation management optimises recovery and delays the time to the next acute episode.

Methods/analysis: The Predict & Prevent AECOPD trial is a phase III, 2 arm, multi-centre, open label, parallel-group individually randomised clinical trial investigating the use of a personalised early warning decision support system (COPDPredictTM) to predict and prevent acute exacerbations of COPD. We aim to recruit 384 participants and randomise each individual in a 1:1 ratio to either standard self-management plans (SSMP) with Rescue Medication (RM) (control arm) or COPDPredictTM with RM (intervention arm).

The trial will inform the future standard of care regarding management of exacerbations in COPD patients. The main outcome measure is to provide further validation, as compared to usual care, for the clinical effectiveness of COPDPredictTM to help guide and support COPD patients and their respective clinical teams in identifying exacerbations early, with an aim to reduce the total number of AECOPD-induced hospital admissions in the 12 months following each patient’s randomisation.

Ethics and Dissemination: This study protocol is reported in accordance with the guidance set out in the SPIRIT statement. Predict and Prevent AECOPD has obtained ethical approval in England (19/LO/1939). Upon completion of the trial and publication of results a lay findings summary will be disseminated to trial participants.

Trials Registration: Clinical trials.gov NCT04136418
Original languageEnglish
Article numbere061050
Number of pages8
JournalBMJ open
Volume13
Issue number3
DOIs
Publication statusPublished - 13 Mar 2023

Keywords

  • Respiratory
  • COPD
  • Exacerbations
  • Symptom Control Markers
  • COPDPredictTM

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