Innate Immunity in COPD (NCT05743582) | Clinical Trial Compass
RecruitingNot Applicable
Innate Immunity in COPD
United Kingdom189 participantsStarted 2023-05-11
Plain-language summary
Chronic Obstructive Pulmonary Disease (COPD) causes obstruction to airflow when breathing out. It is a leading cause of chronic lung disease, hospitalization and death. Smoking is the major cause of COPD but why some smokers develop COPD while others do not is poorly understood. A central feature of COPD is accumulation of inflammatory blood cells, macrophages and neutrophils, in the airway, leading to lung injury and airway damage. The small airways of many patients with COPD contain bacteria, which are absent in healthy smokers or non-smokers. These bacteria stimulate recruitment of neutrophils, macrophages and other inflammatory cells, further accelerating airway injury. The investigators and others have shown resident macrophages in the lung and inflammatory cells (neutrophils and macrophages) recruited from the blood, which normally clear bacteria, have reduced anti-bacterial capacity in COPD and that their altered function impairs the resolution of inflammation. The investigators now wish to test why these cells fail to clear bacteria focusing in particular on how they use molecules as food to generate energy, a process termed metabolism, since this is an important determinant of immune cell function. Comparison will be made between lung resident cells (obtained by performing bronchoscopy and washing a segment of lung to flush out immune cells) and those from the blood to determine if the alterations are specific to the lung. The investigators will identify alterations in responses to bacteria in relation to changes in metabolism . A major focus will be on how structures in the cell that normally are key for energy production (i.e. mitochondria) become dysfunctional and how this impacts responses to bacteria. The investigators will relate findings to the clinical features of COPD and to healthy non-smokers and smokers to separate smoking-related changes from COPD. The aim is to develop new approaches with which to treat and manage COPD.
Who can participate
Age range
18 Years – 77 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
COPD patients:
* COPD patients aged 18-77 years who are GOLD Stage 1 or 2 or 3; for patients undergoing bronchoscopy already for a clinical reason.
* COPD patients aged 18-77 years old who are GOLD Stage 1,2 or 3 for patients who are donating blood only.
* COPD patients aged 18-69 years who are GOLD Stage 1 or 2 for patients undergoing bronchoscopy for research purposes.
* COPD- Defined by radiological investigation of chest either chest X-ray or High-resolution CT scan in previous 12 months
* Ability to provide informed consent
Healthy volunteers:
* Any healthy volunteer aged 18-77 years
* Ability to provide informed consent
Exclusion Criteria:
COPD patients:
* 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 \>250 ml of blood for any reason within the last 6 months
* Individuals who are pregnant or breast feeding.
* Current participation in any other clinical trial, except those directly relating to this cohort and study.
* Individuals who have had a febrile illness or other symptoms of acute infectious illness (respiratory, enteric or soft tissue) within the last 2 weeks
* Individuals who have received a vaccine in the past 2 weeks
* Inability to communicate in English or convey willingness to participate.
* For bronchoscopy - Any significant lung condition that would contra-indicate bronchoscopy incl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be focused on studying how immune cells fight infections in COPD rather than testing a new treatment — can you explain what that means for me practically, and whether participating would change anything about my current care?
2Since this trial is in phase 'NA' and is focused on identifying immune responses rather than testing a drug or intervention, what exactly would be asked of me as a participant — things like blood draws, biopsies, or other procedures?
3Given that this study is about understanding the basic biology of COPD and immunity, would joining it give me any direct benefit, or is it mainly contributing to future research that might help others down the line?
4Are there standard treatments for my COPD that I should be prioritizing right now, and would participating in an observational study like this interfere with or delay any of those options?
5Since the trial is actively recruiting, how long would my involvement last, and are there specific COPD severity levels or other criteria that my doctor thinks would make this a good or poor fit for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of immunometabolic responses in immune cells required for microbicidal activity.