UnknownNot Applicable

Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD (Colour COPD)

United Kingdom2,954 participantsStarted 2021-12-14

Plain-language summary

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. There are also a range of other secondary objectives as detailed in the secondary outcomes section. An integral pilot phase, economic evaluation and process evaluation are also included.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinically diagnosed COPD, confirmed by a medical record of post-bronchodilator spirometry denoting obstruction. * ≥2 AECOPD in the 12 months prior to screening according to the patient or ≥1 hospital admission for AECOPD (i.e. Global Initiative for Chronic Obstructive Lung Disease- GOLD; C or D). * Able to safely use SM plan in the view of their usual care practitioner * Able to use sputum colour chart; this will be confirmed by a sight test if there is any doubt on initial assessment by the usual care or research team. Patients who report being colour blind will have their ability to use the chart tested at the screening visit. * Written Informed consent given Additionally, to participate in the E-diary sub-study. - Access to smartphone/tablet and an email address. Additionally, to participate in the Sputum sub-study. \- Chronic bronchitis, defined by self-reported sputum production for at least 3 months in each of 2 consecutive years or more. Exclusion Criteria: * Household member already participating in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of hospital admissions where the primary reason for admission is AECOPD

Timeframe: 12 months post randomisation

Trial details

NCT IDNCT04705233

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-04

Contact for this trial

Sarah Moorlock

+44 (0)121 41 s.j.moorlock@bham.ac.uk

View on ClinicalTrials.gov More Pulmonary Disease, Chronic Obstructive trials