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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: sputum colour chart

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 Type: Interventional
• Enrollment (Anticipated): 2954
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Moorlock; Phone Number: 48137 +44 (0)121 41; Email: s.j.moorlock@bham.ac.uk
• Study Contact Backup: Name: Sarah Tearne; Email: S.Clarke.2@bham.ac.uk

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • West Midlands Clinical Research Network
    • Contact: Anuradha Krishna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sputum chart; 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	Other: sputum colour chart; 5-point Sputum Colour Chart plus best standard care
NO_INTERVENTION: Control; Use of the plan and rescue pack alone (best usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of self-reported AECOPD every 3 months	Self-reported AECOPD (including those for which admission is required) obtained by telephone calls	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	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	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	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	12 months post randomisation
Number of participant deaths from all causes	All-cause mortality taken from HES and/or medical records	12 months post randomisation
Number of unscheduled GP visits for AECOPD	Self-reported unscheduled GP visits for AECOPD	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	12 months post randomisation
Number of prescriptions for oral anti-fungals	Self-reported prescriptions for oral anti-fungals (e.g. for oral thrush)	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	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	3, 6, 9 and 12 months post randomisation
Antibiotic resistance	identification of antibiotic resistant pathogens within sputum culture	at baseline, all AECOPD and 12 months post randomisation
Healthcare resource utilisation	determined from participant self-report on bespoke questionnaire (in development)	3, 6 and 9 and 12 months post randomisation

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Salford Royal Foundation Trust
• Investigators: Principal Investigator: Alice Turner, The University of Birmingham and University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2021
• Primary Completion (ANTICIPATED): March 4, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (ACTUAL): January 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Primary Care; COPD; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Sputum; Patient Care; Primary Healthcare; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Airflow Obstruction,; Chronic COAD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RG_18-088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No