COPDNCT03161561
Mechanisms and Impact of Bacterial Colonisation in COPD
A study testing capacity of primary phagocytes in people with COPD, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
COPD is a leading cause of lung disease and a common cause of hospitalisation, time off work and death. Smoking is the major factor associated with development of COPD. Nevertheless why some people develop COPD while others, including many smokers do not, is poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- capacity of primary phagocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Nov 2011to 1 Feb 2018
- Phase
- Interventional
- 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
COPD Patients Inclusion Criteria:
aged 18-69 GOLD stage I or II have defined exacerbation frequency
Healthy Volunteers Inclusion Criteria:
age and sex matched to recruited COPD patients either non-smokers or smokers with at least 10 years history of smoking at least 10 cigarettes per day.
COPD Patients Exclusion Criteria:
Individuals known to have active malignancy, immunosuppression, diabetes mellitus, chronic kidney disease or hepatic failure.
Individuals with a history of anaemia Individuals who have donated >200 ml of blood for any reason within the last 6months Individuals who are pregnant or breast feeding. Current participation in any other clinical trial, except those directly relating to this cohort and study.
Inability to communicate in English or convey willingness to participate.
For bronchoscopy - any active lung condition including:
Any active acute lung infection (with the exception of asymptomatic pulmonary colonisation) or malignancy Significant coexisting interstitial lung disease or additional pulmonary diagnosis in addition to COPD Significant interstitial lung disease (on radiological and PFT criteria) Any significant abnormality on CXR that would contraindicate bronchoscopy
Healthy Volunteers Exclusion Criteria:
Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks.
Chronic or acute respiratory disease. Any chronic medical condition or receipt of regular prescription medication other than the oral contraceptive pill.
Individuals who have received a vaccine in the past two weeks. Individuals with a history of anaemia or any symptoms (shortness of breath, chronic fatigue, chest pain or pallor) suggestive of possible anaemia or haemoglobin below the lower limit of sex adjusted normal range.
Individuals who have donated >200 ml of blood for any reason within the last 6 months.
Individuals who are pregnant or breast feeding. Current participation in any clinical trial. Inability to communicate in English or convey willingness to participate
For bronchoscopy - any active lung condition including:
Any lung infection Asthma
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
Official title: Mechanisms, Impact and Therapeutic Targeting of Bacterial Colonisation in COPD
COPD is a leading cause of lung disease and a common cause of hospitalisation, time off work and death. Smoking is the major factor associated with development of COPD. Nevertheless why some people develop COPD while others, including many smokers do not, is poorly understood. A central feature of COPD is accumulation of a particular type of white blood cell, the neutrophil, which is a key component in defence against bacterial infection in the lung airway. As disease progresses the small airways of many patients with COPD start to accumulate bacteria, which are normally lacking in the small airways of healthy individuals or smokers who lack COPD. The accumulation of bacteria in the smaller airways of many patients with COPD may be important to the development of the disease. Researchers will test if blood cells, which normally ingest and kill bacteria, have a reduced ability to perform this function in patients with COPD and whether the clearance of these blood cells after they have performed their role in protecting against infection is impaired. Researchers will relate these findings to the clinical features of COPD in a well-defined group of patients who have had extensive characterisation of their disease. In particular, researchers will relate this defect to the presence of frequent flares of disease, which lead to symptoms of wheezing and shortness of breath. Comparison will be made between blood cells obtained from the lung and from he blood to determine if the alterations are specific to the lung. Researchers will identify particular molecular alterations in the way these blood cells respond to bacteria and determine whether they can correct these alterations using agents, which are used to treat a range of different medical conditions, but which they predict might correct these alterations in function. The aim of this programme of work is ultimately to identify new ways in which to treat COPD and the agents, which the researchers demonstrate have the greatest potential to correct the abnormalities in cell function of patients with COPD, would in the future be studied in clinical trials.
Read the detailed description
Work package one involves the consolidation and further characterisation of a number of pre-existing UK-based clinical cohorts of patients with COPD. This involves collection of epidemiological and physiological data from patients and controls to enable a complete definition of disease phenotype. Work package two will examine microbiological and innate immune parameters in this cohort to define whether innate immune defects underpin the susceptibility to infectious exacerbation and progression of airways disease. It will perform microbiological characterisation of each group and will look at the behaviour of groups who have frequent infectious exacerbations of disease as compared to those that do not. Work package three will measure lung injury and work package four will define physiological characteristics including chest wall muscle function in the cohort.
Our work will sit within work package two. Researchers will collect data from patients within the cohort and in patients whom they may recruit locally and add to the cohort. Researchers will also share samples with other work packages (academic and industry based collaborators) as required to enable correlation of our findings with other investigators in our work package or other work packages. This project, which sits within work-package two will measure the capacity of primary phagocytes (neutrophils, monocytes and macrophages) isolated from COPD patients' blood or alveolar macrophages isolated from patients' lungs to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls.
- Conditions
- COPD
- Being tested
- capacity of primary phagocytes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capacity of primary phagocytesOther
measurement of capacity of primary phagocytes (neutrophils, monocytes and macrophages) isolated from COPD patients' blood or alveolar macrophages isolated from patients' lungs to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls.
| Study group | Role | What they receive |
|---|---|---|
| capacity of primary phagocytes | Other | capacity of primary phagocytes isolated from COPD patients' blood to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls. Receives: Other: capacity of primary phagocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
JC-1 assay of phagocytosis
Using preliminary data derived from the performance of one of the assays to be performed to measure apoptosis on these patient's macrophages, the JC-1 assay of loss of inner mitochondrial transmembrane potential
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start16 Nov 2011
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Measurement of the capacity of primary phagocytes (neutrophils, monocytes and macrophages) isolated from COPD patients' blood or alveolar macrophages isolated from patients' lungs to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Collini, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161561
- Sponsor's protocol ID
- STH15949
- Status last verified
- Feb 2019
- First submitted
- 11 May 2017
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms, Impact and Therapeutic Targeting of Bacterial Colonisation in COPD
- ClinicalTrials.gov ID
- NCT03161561
- Acronym / sponsor ID
- STH15949
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Nov 2011 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 22 May 2017 (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.
COPD is a leading cause of lung disease and a common cause of hospitalisation, time off work and death. Smoking is the major factor associated with development of COPD. Nevertheless why some people develop COPD while others, including many smokers do not, is poorly understood. A central feature of COPD is accumulation of a particular type of white blood cell, the neutrophil, which is a key component in defence against bacterial infection in the lung airway. As disease progresses the small airways of many patients with COPD start to accumulate bacteria, which are normally lacking in the small airways of healthy individuals or smokers who lack COPD. The accumulation of bacteria in the smaller airways of many patients with COPD may be important to the development of the disease. Researchers will test if blood cells, which normally ingest and kill bacteria, have a reduced ability to perform this function in patients with COPD and whether the clearance of these blood cells after they have performed their role in protecting against infection is impaired. Researchers will relate these findings to the clinical features of COPD in a well-defined group of patients who have had extensive characterisation of their disease. In particular, researchers will relate this defect to the presence of frequent flares of disease, which lead to symptoms of wheezing and shortness of breath. Comparison will be made between blood cells obtained from the lung and from he blood to determine if the alterations are specific to the lung. Researchers will identify particular molecular alterations in the way these blood cells respond to bacteria and determine whether they can correct these alterations using agents, which are used to treat a range of different medical conditions, but which they predict might correct these alterations in function. The aim of this programme of work is ultimately to identify new ways in which to treat COPD and the agents, which the researchers demonstrate have the greatest potential to correct the abnormalities in cell function of patients with COPD, would in the future be studied in clinical trials.
Detailed description
Work package one involves the consolidation and further characterisation of a number of pre-existing UK-based clinical cohorts of patients with COPD. This involves collection of epidemiological and physiological data from patients and controls to enable a complete definition of disease phenotype. Work package two will examine microbiological and innate immune parameters in this cohort to define whether innate immune defects underpin the susceptibility to infectious exacerbation and progression of airways disease. It will perform microbiological characterisation of each group and will look at the behaviour of groups who have frequent infectious exacerbations of disease as compared to those that do not. Work package three will measure lung injury and work package four will define physiological characteristics including chest wall muscle function in the cohort.
Our work will sit within work package two. Researchers will collect data from patients within the cohort and in patients whom they may recruit locally and add to the cohort. Researchers will also share samples with other work packages (academic and industry based collaborators) as required to enable correlation of our findings with other investigators in our work package or other work packages. This project, which sits within work-package two will measure the capacity of primary phagocytes (neutrophils, monocytes and macrophages) isolated from COPD patients' blood or alveolar macrophages isolated from patients' lungs to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Measurement of the capacity of primary phagocytes (neutrophils, monocytes and macrophages) isolated from COPD patients' blood or alveolar macrophages isolated from patients' lungs to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls.
| Arm | Type | Receives |
|---|---|---|
| capacity of primary phagocytes | Other | Other: capacity of primary phagocytescapacity of primary phagocytes isolated from COPD patients' blood to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capacity of primary phagocytesmeasurement of capacity of primary phagocytes (neutrophils, monocytes and macrophages) isolated from COPD patients' blood or alveolar macrophages isolated from patients' lungs to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls. | Other | capacity of primary phagocytes |
Primary outcome
JC-1 assay of phagocytosis
Time frame: day 0
Using preliminary data derived from the performance of one of the assays to be performed to measure apoptosis on these patient's macrophages, the JC-1 assay of loss of inner mitochondrial transmembrane potential
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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.
Paul Collini principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capacity of primary phagocytes in people with COPD, run by Sheffield Teaching Hospitals NHS Foundation Trust 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?
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: finished, as of the sponsor's last update on 15 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
JC-1 assay of phagocytosis (time frame: day 0). 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 15 Feb 2019.