Clinical trial NCT04705233: Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD (Colour COPD)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Primary Healthcare
Patient Care
Chronic Bronchitis
Sputum
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Salford Royal Foundation Trust
First posted: 2021-01-12
Enrollment: 2954
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2 arm, multi-centre, open label, parallel-group randomised designed trial
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of hospital admissions where the primary reason for admission is AECOPD
timeFrame: 12 months post randomisation
Secondary outcomes:
measure: Number of self-reported AECOPD every 3 months
timeFrame: 3, 6, 9 and 12 months post randomisation
measure: Number of Self-reported antibiotic and steroid prescriptions for AECOPD
timeFrame: 3, 6, 9 and 12 months post randomisation
measure: Number of all cause hospital admissions
timeFrame: 12 months post randomisation
measure: Number of readmissions to hospital for AECOPD at 30 and 90 days
timeFrame: 12 months post randomisation
measure: Number of Bed days due to AECOPD
timeFrame: 12 months post randomisation
measure: Number of participant deaths from all causes
timeFrame: 12 months post randomisation
measure: Number of unscheduled GP visits for AECOPD
timeFrame: 12 months post randomisation
measure: Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure)
timeFrame: 12 months post randomisation
measure: Number of prescriptions for oral anti-fungals
timeFrame: 12 months post randomisation
measure: Quality of life by COPD assessment test
timeFrame: 3, 6, 9 and 12 months post randomisation
measure: Quality of life measured using the EuroQoL-5Dimension-5Level questionnaire
timeFrame: 3, 6, 9 and 12 months post randomisation
measure: Antibiotic resistance
timeFrame: at baseline, all AECOPD and 12 months post randomisation
measure: Healthcare resource utilisation
timeFrame: 3, 6 and 9 and 12 months post randomisation
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: West Midlands Clinical Research Network
Study officials:
affiliation: The University of Birmingham and University Hospitals NHS Foundation Trust
name: Alice Turner
role: PRINCIPAL_INVESTIGATOR
References: