Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD (Colour COPD)
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
1 other identifier
interventional
2,954
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Start
First participant enrolled
December 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedNovember 10, 2022
May 1, 2022
1.2 years
January 8, 2021
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
12 months post randomisation
Secondary Outcomes (13)
Number of self-reported AECOPD every 3 months
3, 6, 9 and 12 months post randomisation
Number of Self-reported antibiotic and steroid prescriptions for AECOPD
3, 6, 9 and 12 months post randomisation
Number of all cause hospital admissions
12 months post randomisation
Number of readmissions to hospital for AECOPD at 30 and 90 days
12 months post randomisation
Number of Bed days due to AECOPD
12 months post randomisation
- +8 more secondary outcomes
Study Arms (2)
Sputum chart
EXPERIMENTALUse 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 INTERVENTIONUse of the plan and rescue pack alone (best usual care)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Household member already participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- Salford Royal Foundation Trustcollaborator
Study Sites (1)
West Midlands Clinical Research Network
Birmingham, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Turner
The University of Birmingham and University Hospitals NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2021
First Posted
January 12, 2021
Study Start
December 14, 2021
Primary Completion
March 4, 2023
Study Completion
December 30, 2023
Last Updated
November 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
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.