COPD in the Time of COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This cross-sectional observational study will collect information about changes in exacerbation frequency and behaviour amongst a clinical cohort of severe or complex COPD clinic patients. This will be done through a combination of telephone survey and access to electronic heath records.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be a cross-sectional observational study utilising a telephone survey.

After obtaining informed verbal consent participants will be asked to recall their symptoms, exacerbation events and exacerbation medication usage over the periods of 01/03/20 - 14/03/20 (pre-lockdown) and then 15/03/20 to 30/04/20 (lockdown).

A structured survey will follow on from this asking questions regarding behaviour including self-isolation, shielding, other household contacts, visitors to the home, arrangements for shopping, changes in smoking behaviour (including that of other smokers in the household), medication changes, self-reported change in use of preventer medication, self-reported change in walking/activity levels and self-reported changes in anxiety levels.

Baseline clinical data will subsequently also be collected from the comprehensive respiratory review previously performed in the complex COPD clinic (comprising both hospital and GP records.) This will include previous AECOPD phenotyping (eosinophil levels, sputum culture and viral PCR), previous lung function testing, prescribed medication, BMI and smoking status and history. Previous AECOPD events will be counted and graded based on GP antibiotic or steroid prescriptions and hospital admissions.

Participants will be contacted once as part of the main study following verbal informed consent (via telephone). This will be a brief survey as described above, lasting approximately 20 minutes. A second similar survey will take place up to 12 months after the initial contact to evaluate longitudinal changes associated with the lockdown (further details on this will be submitted as an amendment at a later date due the shifting and unpredictable nature of the COVID-19 pandemic and lockdown, this will be prior to initiating these second calls).

Additional clinical data will be collected from healthcare records to quantify disease severity. Participant postcodes will be collected to link results with changes in local air pollution as recorded or estimated during the COVID-19 lockdown.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glenfield Complex COPD Clinic Cohort

Patients previously seen in the complex COPD clinic at the Glenfield Hospital.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Confirmed clinical diagnosis of COPD
2. Ability to provide informed verbal consent via English language telephone consultation
3. Adults aged over 40 years

Exclusion Criteria

1. Patients currently admitted to hospital
2. Unwilling/unable to provide informed consent

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neil J Greening, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital

Leicester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0778

Identifier Type: -

Identifier Source: org_study_id