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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705233
• Other study ID #: RG_18-088
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2022
• Source: University of Birmingham
• Contact: Sarah Moorlock
• Phone: +44 (0)121 41
• Email: s.j.moorlock[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2954
• Est. completion date: December 30, 2023
• Est. primary completion date: March 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• sputum colour chart
5-point Sputum Colour Chart plus best standard care

Locations

Country	Name	City	State
United Kingdom	West Midlands Clinical Research Network	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Salford Royal Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participant deaths from all causes	All-cause mortality taken from HES and/or medical records	12 months post randomisation
Secondary	Number of unscheduled GP visits for AECOPD	Self-reported unscheduled GP visits for AECOPD	12 months post randomisation
Secondary	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
Secondary	Number of prescriptions for oral anti-fungals	Self-reported prescriptions for oral anti-fungals (e.g. for oral thrush)	12 months post randomisation
Secondary	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
Secondary	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
Secondary	Antibiotic resistance	identification of antibiotic resistant pathogens within sputum culture	at baseline, all AECOPD and 12 months post randomisation
Secondary	Healthcare resource utilisation	determined from participant self-report on bespoke questionnaire (in development)	3, 6 and 9 and 12 months post randomisation