Understanding immune responses in COPD patients
Analysis of Innate Immune Competence in People With Chronic Obstructive Pulmonary Disease (COPD)
This study is trying to understand how the immune system works in people with COPD when they face bacterial infections to help find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 189 (estimated) |
| Ages | 18 Years to 77 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 2 sites (Edinburgh and 1 other locations) |
| Trial ID | NCT05743582 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of innate immunity in patients with Chronic Obstructive Pulmonary Disease (COPD). It focuses on the behavior of immune cells, such as alveolar macrophages and neutrophils, in response to bacterial infections that exacerbate the condition. By collecting samples through bronchoscopy and blood donation, researchers will analyze the immune cell metabolism and bactericidal mechanisms in COPD patients compared to healthy volunteers. The goal is to better understand the chronic inflammatory processes in COPD to inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include COPD patients aged 18-77 years who are at GOLD Stage 1, 2, or 3, as well as healthy volunteers within the same age range.
Not a fit: Patients with active malignancy, immunosuppression, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments that effectively address the chronic inflammation in COPD, improving patient outcomes.
How similar studies have performed: While there have been studies on COPD and immune responses, this specific approach focusing on innate immunity and bacterial interactions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 including: 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. Healthy volunteers: * Individuals known to have active malignancy, immunosuppression, diabetes mellitus, chronic kidney disease or hepatic failure * Individuals with anaemia on the screening full blood count (FBC) * Individuals who 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 * 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 * Chronic or acute respiratory disease. * Any chronic medical condition or receipt of regular prescription medication other than the oral contraceptive pill. * Inability to communicate in English or convey willingness to participate * For bronchoscopy - Any active lung condition including any lung infection or asthma Any significant abnormality on CXR that would contraindicate bronchoscopy FEV1 \<65% predicted (BTS Guidelines, 2001)
Where this trial is running
Edinburgh and 1 other locations
- University of Edinburgh — Edinburgh, United Kingdom (Not_yet_recruiting)
- Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David H Dockrell, MD — University of Edinburgh
- Study coordinator: David H Dockrell, MD
- Email: David.Dockrell@ed.ac.uk
- Phone: +441312426213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.