Pulmonary Disease, Chronic ObstructiveNCT04705233
Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD (Colour COPD)
A study testing sputum colour chart in people with Pulmonary Disease, Chronic Obstructive, run by University of Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- sputum colour chart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,954 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Household member already participating in the study.
Trial locations and contacts
1 site in 1 country.
Sarah Tearne contact
United Kingdom1 site, 1 recruiting
- Recruiting
West Midlands Clinical Research Network
Birmingham
Anuradha Krishna
About this study
Official title: A 2 Arm, Multi-centre, Open Label, Parallel-group Randomised 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
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.
Read the detailed description
This study is a pragmatic, individually randomized trial, set in primary care, comparing usual care to the use of a sputum colour chart in patients at risk of hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD), with the hypothesis that use of a colour chart will be non-inferior to usual care with respect to hospital admission rate after 12 months of follow-up, this being the primary outcome measure. Use of a chart might reduce antibiotic use, and thus might also change patterns of antibiotic resistance long term, such that these are important secondary outcomes. There is an internal pilot phase, a detailed process evaluation and a cost-effectiveness study.
The trial protocol also includes three sub-studies: 1) using a daily electronic symptom diary capable of picking up symptom defined (but potentially unreported) AECOPD, since these are an important prognostic marker (section 3); 2) collecting sputum samples from patients to assess patterns of antibiotic resistance and 3) a qualitative study which will include staff (for example, healthcare staff delivering the intervention) and patients.
This trial uses a sputum colour chart as part of a self-management intervention that enables patients with COPD to determine whether they have an exacerbation, and whether this requires antibiotic treatment. The 5 point sputum colour chart, adapted from Bronkotest® is being used.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- sputum colour chart
- Keywords
- Airflow Obstruction,, Chronic COAD, COPD, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease, Primary Care, Primary Healthcare, Patient Care, Chronic Bronchitis, Sputum
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sputum colour chartOther
5-point Sputum Colour Chart plus best standard care
| Study group | Role | What they receive |
|---|---|---|
| Sputum chart | Experimental | Use of the 5 point sputum colour chart, adapted from Bronkotest® a self-management (SM) plan and rescue pack (RP) containing 5 days supply of antibiotic and steroid treatment Receives: Other: sputum colour chart |
| Control | No intervention | Use of the plan and rescue pack alone (best usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital admissions where the primary reason for admission is AECOPD
A binary outcome assessing incidence of at least one AECOPD over 12 months after randomisation where patients needed hospitalisation (defined by hospital discharge letter/coding).
Measured: 12 months post randomisation
Secondary outcomes (13)
Number of self-reported AECOPD every 3 months
Self-reported AECOPD (including those for which admission is required) obtained by telephone calls
Measured: 3, 6, 9 and 12 months post randomisation
Number of Self-reported antibiotic and steroid prescriptions for AECOPD
Self-reported number of hospitalisations due to AECOPD obtained by telephone calls
Measured: 3, 6, 9 and 12 months post randomisation
Number of all cause hospital admissions
All cause hospital admission taken from Hospital Episode Statistics (HES) and/or participant self-report
Measured: 12 months post randomisation
Number of readmissions to hospital for AECOPD at 30 and 90 days
Readmissions to hospital for AECOPD at 30 and 90 days taken from HES and/or participant self-report
Measured: 12 months post randomisation
Number of Bed days due to AECOPD
Total in hospital bed days due to AECOPD taken from HES and/or participant self-report
Measured: 12 months post randomisation
Number of participant deaths from all causes
All-cause mortality taken from HES and/or medical records
Measured: 12 months post randomisation
Number of unscheduled GP visits for AECOPD
Self-reported unscheduled GP visits for AECOPD
Measured: 12 months post randomisation
Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure)
Self-reported prescriptions for 2nd courses of antibiotics within 14 days of self-reported
Measured: 12 months post randomisation
Number of prescriptions for oral anti-fungals
Self-reported prescriptions for oral anti-fungals (e.g. for oral thrush)
Measured: 12 months post randomisation
Quality of life by COPD assessment test
Quality of life measured using the COPD assessment test (CAT) at 3 monthly intervals
Measured: 3, 6, 9 and 12 months post randomisation
Quality of life measured using the EuroQoL-5Dimension-5Level questionnaire
Measured at 3 monthly intervals. The EQ-5D-5L generates a score from 5 to 25 (5 being 'no problem' on all of the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression), the total score will be used for the economic evaluation only
Measured: 3, 6, 9 and 12 months post randomisation
Antibiotic resistance
identification of antibiotic resistant pathogens within sputum culture
Measured: at baseline, all AECOPD and 12 months post randomisation
Healthcare resource utilisation
determined from participant self-report on bespoke questionnaire (in development)
Measured: 3, 6 and 9 and 12 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start14 Dec 2021
- Primary completion4 Mar 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2 arm, multi-centre, open label, parallel-group randomised designed trial
- Masking
- None (open label)
- Enrolment
- 2,954 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Salford Royal Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alice Turner, Principal investigator, The University of Birmingham and University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705233
- Sponsor's protocol ID
- RG_18-088
- Status last verified
- May 2022
- First submitted
- 8 Jan 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datasets generated and analysed during the current study will be available upon request from Birmingham Clinical Trials Unit (BCTU: bctudatashare@contacts.bham.ac.uk). Data will typically be available within 6 months after the primary publication unless it is not possible to share the data. Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. The request will be reviewed by the BCTU Data Sharing Committee in discussion with the CI and, where appropriate (or in absence of the CI) any of the following: the Trial Sponsor, the relevant Trial Management Group, and the independent Trial Steering Committee. A formal Data Sharing Agreement (DSA) may be required between respective organisations once the release of the data is approved and before data can be released. Data will be fully anonymised unless the DSA covers the transfer of patient identifiable information. Data transfer will use a secure and encrypted method.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Arm, Multi-centre, Open Label, Parallel-group Randomised 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
- ClinicalTrials.gov ID
- NCT04705233
- Acronym / sponsor ID
- RG_18-088
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Airflow Obstruction,, Chronic COAD, COPD, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease, Primary Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,954 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Salford Royal Foundation Trust
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 4 Mar 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a pragmatic, individually randomized trial, set in primary care, comparing usual care to the use of a sputum colour chart in patients at risk of hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD), with the hypothesis that use of a colour chart will be non-inferior to usual care with respect to hospital admission rate after 12 months of follow-up, this being the primary outcome measure. Use of a chart might reduce antibiotic use, and thus might also change patterns of antibiotic resistance long term, such that these are important secondary outcomes. There is an internal pilot phase, a detailed process evaluation and a cost-effectiveness study.
The trial protocol also includes three sub-studies: 1) using a daily electronic symptom diary capable of picking up symptom defined (but potentially unreported) AECOPD, since these are an important prognostic marker (section 3); 2) collecting sputum samples from patients to assess patterns of antibiotic resistance and 3) a qualitative study which will include staff (for example, healthcare staff delivering the intervention) and patients.
This trial uses a sputum colour chart as part of a self-management intervention that enables patients with COPD to determine whether they have an exacerbation, and whether this requires antibiotic treatment. The 5 point sputum colour chart, adapted from Bronkotest® is being used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 2 arm, multi-centre, open label, parallel-group randomised designed trial
| Arm | Type | Receives |
|---|---|---|
| Sputum chart | Experimental | Other: sputum colour chartUse of the 5 point sputum colour chart, adapted from Bronkotest® a self-management (SM) plan and rescue pack (RP) containing 5 days supply of antibiotic and steroid treatment |
| Control | No intervention | –Use of the plan and rescue pack alone (best usual care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Household member already participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sputum colour chart5-point Sputum Colour Chart plus best standard care | Other | Sputum chart |
Primary outcome
Number of hospital admissions where the primary reason for admission is AECOPD
Time frame: 12 months post randomisation
A binary outcome assessing incidence of at least one AECOPD over 12 months after randomisation where patients needed hospitalisation (defined by hospital discharge letter/coding).
13 secondary outcomes
Number of self-reported AECOPD every 3 months
Time frame: 3, 6, 9 and 12 months post randomisation
Number of Self-reported antibiotic and steroid prescriptions for AECOPD
Time frame: 3, 6, 9 and 12 months post randomisation
Number of all cause hospital admissions
Time frame: 12 months post randomisation
Number of readmissions to hospital for AECOPD at 30 and 90 days
Time frame: 12 months post randomisation
Number of Bed days due to AECOPD
Time frame: 12 months post randomisation
Number of participant deaths from all causes
Time frame: 12 months post randomisation
Number of unscheduled GP visits for AECOPD
Time frame: 12 months post randomisation
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
Number of prescriptions for oral anti-fungals
Time frame: 12 months post randomisation
Quality of life by COPD assessment test
Time frame: 3, 6, 9 and 12 months post randomisation
Quality of life measured using the EuroQoL-5Dimension-5Level questionnaire
Time frame: 3, 6, 9 and 12 months post randomisation
Antibiotic resistance
Time frame: at baseline, all AECOPD and 12 months post randomisation
Healthcare resource utilisation
Time frame: 3, 6 and 9 and 12 months post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No. Datasets generated and analysed during the current study will be available upon request from Birmingham Clinical Trials Unit (BCTU: bctudatashare@contacts.bham.ac.uk). Data will typically be available within 6 months after the primary publication unless it is not possible to share the data. Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. The request will be reviewed by the BCTU Data Sharing Committee in discussion with the CI and, where appropriate (or in absence of the CI) any of the following: the Trial Sponsor, the relevant Trial Management Group, and the independent Trial Steering Committee. A formal Data Sharing Agreement (DSA) may be required between respective organisations once the release of the data is approved and before data can be released. Data will be fully anonymised unless the DSA covers the transfer of patient identifiable information. Data transfer will use a secure and encrypted method.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Tearne contact
Alice Turner principal investigator
The University of Birmingham and University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sputum colour chart in people with Pulmonary Disease, Chronic Obstructive, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Moorlock (+44 (0)121 41 ext. 48137, s.j.moorlock@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospital admissions where the primary reason for admission is AECOPD (time frame: 12 months post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.