Colour COPD

logoThe Colour COPD Trial is a randomised controlled trial of usual care (self-management plan) versus usual care plus the use of a sputum colour chart to manage COPD exacerbations (worsening of symptoms).  Colour COPD will recruit patients through Primary Care predominantly from the West Midlands and Greater Manchester areas.

LATEST NEWS

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

Design

Colour COPD is a 2-arm, multi-centre, open, non-inferiority parallel-group, individually randomised designed trial.

Aim of the Study

 

The primary objective of this study is to determine if a sputum colour chart can aid patient self-management of COPD exacerbations, such that use of the chart is non-inferior to usual care with respect to hospital admissions. A range of other secondary objectives are described in the main protocol. An integral pilot phase is included and described in the main protocol. An economic evaluation and process evaluation are also included.

 

Setting

Suitable patients will be identified by GP practices in Primary Care across the West Midlands and Greater Manchester regions.   PIC sites and identification of patients from Secondary Care (e.g. COPD clinics) may also be used and we have permissions in place to recruit patients from other geographical areas across England.

Target Population

2954 men and women, aged 18 or above who have clinically diagnosed COPD, confirmed by a medical record of post-bronchodilator spirometry denoting obstruction
Eligible patients will have had:

  • 2 or more acute exacerbations (AECOPD) 

or

  • one or more hospital admission for AECOPD in the preceding year before screening (i.e. GOLD C or D).

    Intervention

    The experimental arm of the Colour COPD Trial will receive a 5 point sputum colour chart, adapted from Bronkotest® a self-management plan and rescue pack containing 5 days of antibiotic and steroid treatment. 

     

    Participants in both the experimental arm and control arm will receive a screening appointment and 12 month follow up appointment which will be similar to the usual annual COPD review, thus align well to usual care.  These appointments will take place either face-to-face at the GP practice, over a video link or via the telephone. Participants will also receive telephone calls at 2 weeks, and then at 3,6 and 9 months after enrolment, these follow up telephone calls which will be carried out by the research team at the University of Birmingham.