COPD ExacerbationNCT04407598
COPD in the Time of COVID-19
An observational study of COPD Exacerbation and COPD, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation, COPD
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2020to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients known to have COPD and previously seen in the Complex COPD Clinic at the Glenfield Hospital, Leicester.
Who may be able to join
- Confirmed clinical diagnosis of COPD
- Ability to provide informed verbal consent via English language telephone consultation
- Adults aged over 40 years
Who cannot join
- Patients currently admitted to hospital
- Unwilling/unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital
Leicester, LE3 9QG
About this study
Official title: Cross-Sectional Observation Telephone Survey Study to Understand the Changes in COPD Exacerbation Patterns and Potential Causes of These During the COVID-19 Pandemic
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.
Read the detailed description
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
- COPD Exacerbation, COPD
- Keywords
- COPD, AECOPD, COVID-19
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glenfield Complex COPD Clinic Cohort | Patients previously seen in the complex COPD clinic at the Glenfield Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COPD Exacerbation Rate
The primary outcome will be the change in number of moderate or severe AECOPD events over the 46 days from the 15th March, 2020 to 30th April, 2020 compared to the same 46 day period in 2019.
Measured: 46 days
Secondary outcomes (13)
Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.
Measured: 46 days
Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019.
Measured: 46 days
Social contact changes during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Household contacts during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Household visitors during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Regular shopping behaviour during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Medication changes during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Change in physical activity levels during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Change in anxiety levels during i) pre-lockdown and ii) lockdown period
Measured: 46 days
Perceived fear of hospitalisation during COVID-19 period
Measured: 46 days
Patient reported changes in perception of symptoms, need for hospitalisation and availability and safety of healthcare resources thought semi-structured interviews in 20 patients (nested qualitative study)
Measured: 46 days
Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown
Measured: 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 May 2020
- Primary completion8 Jun 2020
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Neil J Greening, PhD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407598
- Sponsor's protocol ID
- 0778
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Observation Telephone Survey Study to Understand the Changes in COPD Exacerbation Patterns and Potential Causes of These During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04407598
- Acronym / sponsor ID
- 0778
- Conditions
- COPD Exacerbation, COPD
- Keywords
- COPD, AECOPD, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 1 May 2020 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glenfield Complex COPD Clinic Cohort | – | –Patients previously seen in the complex COPD clinic at the Glenfield Hospital. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients known to have COPD and previously seen in the Complex COPD Clinic at the Glenfield Hospital, Leicester.
Key inclusion criteria (3 listed)
- Confirmed clinical diagnosis of COPD
- Ability to provide informed verbal consent via English language telephone consultation
- Adults aged over 40 years
Key exclusion criteria (2 listed)
- Patients currently admitted to hospital
- Unwilling/unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in COPD Exacerbation Rate
Time frame: 46 days
The primary outcome will be the change in number of moderate or severe AECOPD events over the 46 days from the 15th March, 2020 to 30th April, 2020 compared to the same 46 day period in 2019.
13 secondary outcomes
Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.
Time frame: 46 days
Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019.
Time frame: 46 days
Social contact changes during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Household contacts during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Household visitors during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Regular shopping behaviour during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Medication changes during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Change in physical activity levels during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Change in anxiety levels during i) pre-lockdown and ii) lockdown period
Time frame: 46 days
Perceived fear of hospitalisation during COVID-19 period
Time frame: 46 days
Patient reported changes in perception of symptoms, need for hospitalisation and availability and safety of healthcare resources thought semi-structured interviews in 20 patients (nested qualitative study)
Time frame: 46 days
Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown
Time frame: 46 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil J Greening, PhD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and COPD, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COPD Exacerbation Rate (time frame: 46 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.