Sputum colour charts to guide antibiotic self-treatment of acute exacerbation of COPD

A two-arm, multi-centre, open-label, parallel-group randomized designed trial investigating the use of sputum colour charts to guide antibiotic self-treatment of acute exacerbation of COPD in patients with COPD (Colour COPD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14955629

Enrollment

2954

Registered

2020-11-11

Start date

2020-11-30

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease Respiratory Chronic obstructive pulmonary disease, unspecified

Interventions

With the support of the Clinical Research Network, potential participants will be identified by pre-screening of GP records and patients will be sent a Patient Information Sheet (PIS) by post to give

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed COPD, confirmed by a medical record of post-bronchodilator spirometry denoting obstruction 2. =2 AECOPD in the 12 months prior to screening according to the patient OR =1 hospital admission for AECOPD (i.e., GOLD C or D)

Exclusion criteria

Exclusion criteria: Household member already participating in the study

Design outcomes

Primary

Measure	Time frame
A binary outcome assessing the incidence of at least one AECOPD over 12 months post randomisation where patients needed hospitalisation (defined by hospital discharge letter/coding). Data will be obtained from NHS digital medical records (hospital episode statistics; HES) which ensures any admissions not reported to the GP are picked up.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 16/02/2021: 1. Number of self-reported AECOPD every 3 months. Time Frame: 3, 6, 9 and 12 months post randomisation 2. Number of self-reported antibiotic and steroid prescriptions for AECOPD. Time Frame: 3, 6, 9 and 12 months post randomisation 3. Number of all cause hospital admissions. Time Frame: 12 months post randomisation taken from Hospital Episode Statistics (HES) and/or participant self-report 4. Number of readmissions to hospital for AECOPD at 30 and 90 days. Time Frame: 12 months post randomisation taken from HES and/or participant self-report 5. Number of Bed days due to AECOPD. Time Frame: 12 months post randomisation taken from HES and/or participant self-report 6. Number of participant deaths from all causes. Time Frame: 12 months post randomisation. All-cause mortality taken from HES and/or medical records 7. Number of unscheduled GP visits for AECOPD. Time Frame: 12 months post randomisation 8. Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure). Time Frame: 12 months post randomisation 9. Number of prescriptions for oral anti-fungals. Time Frame: 12 months post randomisation 10. Quality of life by COPD assessment test. Time Frame: 3, 6, 9 and 12 months post randomisation 11. Quality of life measured using the COPD assessment test (CAT) at 3 monthly intervals 12. Quality of life measured using the EuroQoL-5Dimension-5Level (EQ-5D-5L) questionnaire. Time Frame: 3, 6, 9 and 12 months post randomisation 13. Antibiotic resistance. Time Frame: at baseline, all AECOPD and 12 months post randomisation 14. Healthcare resource utilisation. Time Frame: 3, 6 and 9 and 12 months post randomisation. Determined from participant self-report on bespoke questionnaire _____ Previous secondary outcome measures: 1. Self-reported AECOPD (including those for which admission is required) obtained by telephone calls to patients at 3, 6 and 9 months 2. GP-co	—

Measure

Time frame

Current secondary outcome measures as of 16/02/2021: 1. Number of self-reported AECOPD every 3 months. Time Frame: 3, 6, 9 and 12 months post randomisation 2. Number of self-reported antibiotic and steroid prescriptions for AECOPD. Time Frame: 3, 6, 9 and 12 months post randomisation 3. Number of all cause hospital admissions. Time Frame: 12 months post randomisation taken from Hospital Episode Statistics (HES) and/or participant self-report 4. Number of readmissions to hospital for AECOPD at 30 and 90 days. Time Frame: 12 months post randomisation taken from HES and/or participant self-report 5. Number of Bed days due to AECOPD. Time Frame: 12 months post randomisation taken from HES and/or participant self-report 6. Number of participant deaths from all causes. Time Frame: 12 months post randomisation. All-cause mortality taken from HES and/or medical records 7. Number of unscheduled GP visits for AECOPD. Time Frame: 12 months post randomisation 8. Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure). Time Frame: 12 months post randomisation 9. Number of prescriptions for oral anti-fungals. Time Frame: 12 months post randomisation 10. Quality of life by COPD assessment test. Time Frame: 3, 6, 9 and 12 months post randomisation 11. Quality of life measured using the COPD assessment test (CAT) at 3 monthly intervals 12. Quality of life measured using the EuroQoL-5Dimension-5Level (EQ-5D-5L) questionnaire. Time Frame: 3, 6, 9 and 12 months post randomisation 13. Antibiotic resistance. Time Frame: at baseline, all AECOPD and 12 months post randomisation 14. Healthcare resource utilisation. Time Frame: 3, 6 and 9 and 12 months post randomisation. Determined from participant self-report on bespoke questionnaire _____ Previous secondary outcome measures: 1. Self-reported AECOPD (including those for which admission is required) obtained by telephone calls to patients at 3, 6 and 9 months 2. GP-co

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Countries

England, United Kingdom

Contacts

Public ContactReshma Ali

colourcopd@trials.bham.ac.uk+44 (0)121 415 8444

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026