Status:
UNKNOWN
Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD (Colour COPD)
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Salford Royal Foundation Trust
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
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 respec...
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...
Eligibility Criteria
Inclusion
- 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
- Household member already participating in the study.
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
2954 Patients enrolled
Trial Details
Trial ID
NCT04705233
Start Date
December 14 2021
End Date
December 30 2023
Last Update
November 10 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
West Midlands Clinical Research Network
Birmingham, United Kingdom