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

Last updated: November 8, 2022
Sponsor: University of Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04705233
RG_18-088
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinically diagnosed COPD, confirmed by a medical record of post-bronchodilatorspirometry denoting obstruction.

  • ≥2 AECOPD in the 12 months prior to screening according to the patient or ≥1 hospitaladmission 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 isany doubt on initial assessment by the usual care or research team. Patients whoreport being colour blind will have their ability to use the chart tested at thescreening visit.

  • Written Informed consent given Additionally, to participate in the E-diary sub-study. - Access to smartphone/tablet and anemail address. Additionally, to participate in the Sputum sub-study.

  • Chronic bronchitis, defined by self-reported sputum production for at least 3 months ineach of 2 consecutive years or more.

Exclusion

Exclusion Criteria:

  • Household member already participating in the study.

Study Design

Total Participants: 2954
Study Start date:
December 14, 2021
Estimated Completion Date:
December 30, 2023

Study 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.

Connect with a study center

  • West Midlands Clinical Research Network

    Birmingham,
    United Kingdom

    Active - Recruiting

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