Pulmonary Disease, Chronic ObstructiveNCT04024735
Mechanisms of COPD Exacerbation Recurrence
An observational study of Pulmonary Disease, Chronic Obstructive and COPD Exacerbation, run by University College, London at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease. Patients with COPD are at increased risk of readmission to hospitals within the following 30 days. Hospital readmissions of COPD contribute to clinical and economic burden on society. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, COPD Exacerbation, Patient Readmission
- What is being tested?
- Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samples
- How many people
- 166 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2019to 1 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients admitted to the hospital because of COPD exacerbation.
Who may be able to join
- Patients who have a primary diagnosis of COPD
- Patients admitted to hospital with an exacerbation.
Who cannot join
- Patients in whom an initial diagnosis of an AECOPD is revised to an alternative at a later phase of the study.
- Patients who have a predominant history of asthma
- Patients with a confirmed active malignancy
- Patients who have a predominant history of bronchiectasis.
- Cognitive impairment patients with a Mental Test Score (MTS) of 6 or less.
- Inability to give informed consent to take part in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Free Hospital NHS
London, NW3 2PF
Jaber S Alqahtani, MSc, +447846713703, jaber.alqahtani.18@ucl.ac.uk
About this study
Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease. Patients with COPD are at increased risk of readmission to hospitals within the following 30 days. Hospital readmissions of COPD contribute to clinical and economic burden on society. Understanding why some COPD patients are readmitted remains a key area of unmet need.
To our knowledge, no previous study has fully investigated both the social and clinical risk factors associated with these types of patients. The investigators want to prospectively and comprehensively explore the possible causes, whether clinical or social factors, that cause rehospitalisation. The investigators will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days. This process could lead to a better understanding of the reasons which prevent early hospital readmission for those patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive, COPD Exacerbation, Patient Readmission, Recurrence
- Being tested
- Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samples
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samplesDiagnostic test
We will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge.
Measured: 30 and 90 days
Secondary outcomes (24)
Readmission rate at 30 days and at 3 months
Measured: 30 and 90 days
Prevalence of comorbidities between those who are and are not readmitted within 30 and 90 days.
Measured: 30 and 90 days
Changes in admission-to-discharge in within breath reactance (∆Xrs5Hz) between patients who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Change in the modified Medical Research Council scale (mMRC) at admission, discharge and after 30 days follow-up or at readmission.
It is used to scale breathlessness, ranges from 0 to 4 which higher values represent a worse outcome.
Measured: 30 and 90 days
Change in quality of life by measuring COPD assessment test (CAT) at admission, discharge and after 30 days follow-up or at readmission.
It is used to scale patient's quality of life. Range of CAT scores from 0-40 which higher scores denote a more severe impact of COPD on a patient's life.
Measured: 30 and 90 days
Change in Hospital Anxiety and Depression Scale (HADS) at admission, discharge and after 30 days follow-up or at readmission.
It is used to scale patient's quality of life. The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher score indicates a worse outcome.
Measured: 30 and 90 days
Prevalence of frailty between those who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Change in physical activity level (daily steps) following the discharge between patients who are and are not readmitted.
Step counter (pedometer) will be given to wear throughout the 30 days period to measure the daily steps.
Measured: 30 days
Changes in admission-to-discharge peak inspiration flow rate (PIFR) between patients who are and are not readmitted.
The In-Check DIAL device will be used which is capable of measuring inspiratory flow rates between 0 and 120 L/min. Optimal PIFR, more than 60 L/min; and sub-optimal PIFR, 60 L/min or less).
Measured: 30 and 90 days
Change in white cell count (WCC) blood biomarkers
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in C-reactive protein (CRP) blood biomarker
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in Eosinophils blood biomarker
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in Neutrophils blood biomarker
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in troponin blood biomarker
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in B-type Natriuretic Peptide (BNP) blood biomarker
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in procalcitonin blood biomarker
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in fibrinogen blood biomarker
At admission, discharge and at readmission.
Measured: 30 and 90 days
Change in sputum biomarkers
This is used to assess bacteria species, load and resistance to antibiotics, and markers of inflammation such as IL-8.
Measured: 30 and 90 days
Number of hospital admissions in the previous year.
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Number of exacerbations in the previous year.
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Use of long-term oxygen therapy (LTOT)
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Length of stay (LOS) in hospital
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Use of non-invasive ventilation (NIV)
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Previous admission to the ICU
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jun 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024735
- Sponsor's protocol ID
- 21022
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of COPD Exacerbation Recurrence
- ClinicalTrials.gov ID
- NCT04024735
- Acronym / sponsor ID
- 21022
- Conditions
- Pulmonary Disease, Chronic Obstructive, COPD Exacerbation, Patient Readmission, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 18 Jul 2019 (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.
Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease. Patients with COPD are at increased risk of readmission to hospitals within the following 30 days. Hospital readmissions of COPD contribute to clinical and economic burden on society. Understanding why some COPD patients are readmitted remains a key area of unmet need.
To our knowledge, no previous study has fully investigated both the social and clinical risk factors associated with these types of patients. The investigators want to prospectively and comprehensively explore the possible causes, whether clinical or social factors, that cause rehospitalisation. The investigators will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days. This process could lead to a better understanding of the reasons which prevent early hospital readmission for those patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients admitted to the hospital because of COPD exacerbation.
Key inclusion criteria (2 listed)
- Patients who have a primary diagnosis of COPD
- Patients admitted to hospital with an exacerbation.
Key exclusion criteria (6 listed)
- Patients in whom an initial diagnosis of an AECOPD is revised to an alternative at a later phase of the study.
- Patients who have a predominant history of asthma
- Patients with a confirmed active malignancy
- Patients who have a predominant history of bronchiectasis.
- Cognitive impairment patients with a Mental Test Score (MTS) of 6 or less.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samplesWe will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days. | Diagnostic test | – |
Primary outcome
The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge.
Time frame: 30 and 90 days
24 secondary outcomes
Readmission rate at 30 days and at 3 months
Time frame: 30 and 90 days
Prevalence of comorbidities between those who are and are not readmitted within 30 and 90 days.
Time frame: 30 and 90 days
Changes in admission-to-discharge in within breath reactance (∆Xrs5Hz) between patients who are and are not readmitted to the hospital within 30 and 90 days.
Time frame: 30 and 90 days
Change in the modified Medical Research Council scale (mMRC) at admission, discharge and after 30 days follow-up or at readmission.
Time frame: 30 and 90 days
Change in quality of life by measuring COPD assessment test (CAT) at admission, discharge and after 30 days follow-up or at readmission.
Time frame: 30 and 90 days
Change in Hospital Anxiety and Depression Scale (HADS) at admission, discharge and after 30 days follow-up or at readmission.
Time frame: 30 and 90 days
Prevalence of frailty between those who are and are not readmitted to the hospital within 30 and 90 days.
Time frame: 30 and 90 days
Change in physical activity level (daily steps) following the discharge between patients who are and are not readmitted.
Time frame: 30 days
Changes in admission-to-discharge peak inspiration flow rate (PIFR) between patients who are and are not readmitted.
Time frame: 30 and 90 days
Change in white cell count (WCC) blood biomarkers
Time frame: 30 and 90 days
Change in C-reactive protein (CRP) blood biomarker
Time frame: 30 and 90 days
Change in Eosinophils blood biomarker
Time frame: 30 and 90 days
Change in Neutrophils blood biomarker
Time frame: 30 and 90 days
Change in troponin blood biomarker
Time frame: 30 and 90 days
Change in B-type Natriuretic Peptide (BNP) blood biomarker
Time frame: 30 and 90 days
Change in procalcitonin blood biomarker
Time frame: 30 and 90 days
Change in fibrinogen blood biomarker
Time frame: 30 and 90 days
Change in sputum biomarkers
Time frame: 30 and 90 days
Number of hospital admissions in the previous year.
Time frame: 30 and 90 days
Number of exacerbations in the previous year.
Time frame: 30 and 90 days
Use of long-term oxygen therapy (LTOT)
Time frame: 30 and 90 days
Length of stay (LOS) in hospital
Time frame: 30 and 90 days
Use of non-invasive ventilation (NIV)
Time frame: 30 and 90 days
Previous admission to the ICU
Time frame: 30 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Pulmonary Disease, Chronic Obstructive and COPD Exacerbation, run by University College, London 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 2 inclusion and 6 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 18 Jul 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge. (time frame: 30 and 90 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 18 Jul 2019.