At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Blood eosinophil count (diagnostic test)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- Blood eosinophil count — diagnostic test: To determine the time it takes for blood eosinophil count to recover to baseline stable state following severe exacerbation of COPD associated with admission eosinopenia and to explore independent factors associated with admission eosinopenia.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 35 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2024-01-22
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for chronic obstructive pulmonary disease
- • Clinical study - 200 participants
- • The goals of this observational study are to identify factors independently associated with admission eosinopenia in patients with a severe exacerbation of chronic obstructive pulmonary disease (COPD) and to determine when blood eosinophil count (BEC) will recover to baseline stable state in patients who are admitted to hospital with a severe exacerbation of COPD and associated eosinopenia
Who can take part?
- • Ages 35 Years and over
- • Diagnosed with chronic obstructive pulmonary disease
Where?
- • North Shields - Northumbria Healthcare NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goals of this observational study are to identify factors independently associated with admission eosinopenia in patients with a severe exacerbation of chronic obstructive pulmonary disease (COPD) and to determine when blood eosinophil count (BEC) will recover to baseline stable state in patients who are admitted to hospital with a severe exacerbation of COPD and associated eosinopenia. The main aims of the study are to: 1. Identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD 2. Assess the time to recovery from eosinopenia to stable BEC following a severe exacerbation of COPD
More detail
Blood eosinophils are a type of white blood cell that play a role in the immune system including fighting infection. They have numerous roles but are primarily involved in inflammation. They are recruited from the blood into sites of inflammation. The blood eosinophil count (BEC) can be used as a biomarker to predict whether the addition of inhaled corticosteroid (ICS) to long-acting bronchodilators (LABD) will be beneficial in reducing future COPD exacerbations. This association is based on BEC being measured when patients are clinically stable. Patients with a higher BEC are more likely to gain these benefits where as conversely, patients with a lower BEC are less likely to benefit and the risk of side effects such as pneumonia will likely outweigh any potential benefit. Current national and international COPD guidelines suggest the use of BEC as a biomarker to help inform the decision of whether to commence or withdraw ICS, but do not specify measuring BEC at a time of clinical stability. Decisions regarding changes to management are often made in the acute setting. Eosinophils transiently drop to very low levels in half of patients who are admitted to hospital with exacerbations of COPD. Measuring BEC during an acute illness risks incorrectly identifying all patients who may benefit from the introduction of an ICS. In the current BEC COPD study, reliance on admission and discharge BEC inappropriately denied ICS to 47% and 33% of patients respectively compared to a confirmed stable-state measure. There are co-primary aims for this study. Firstly, the investigators wish to determine when BEC will recover to stable state following a hospital admission for exacerbation of COPD. Determining this will inform healthcare professionals of the optimum time to measure BEC for use as a biomarker when making decisions related to management escalation. Based on the results of BEC COPD, it is likely that an increased number of patients will be identified as being above the BEC threshold and therefore likely to benefit from ICS when time is allowed for BEC to recover to stable state. Appropriate introduction of ICS in this patient group will reduce exacerbation and hospital re-admission rates and thus may reduce overall mortality within this high-risk group. This should reduce the burden of COPD on patient's health, quality of life and the NHS. Eosinopenia during severe exacerbation of COPD is associated with increased in-hospital and one year mortality. Treatment with oral corticosteroids does not fully explain the mechanism behind the development of eosinopenia, with the phenomenon being less common on discharge compared to admission despite inpatient oral corticosteroid treatment. The investigators other co-primary aim is to identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD, providing useful mechanistic information regarding the relationship between BEC and short-term mortality. The hypothesis for this study is that 90% of participants who are admitted to hospital with a severe exacerbation of COPD and eosinopenia will have recovery of their BEC to baseline stable state within 4 weeks. The investigators also hypothesize that there are demographic, physiological and clinical factors independently associated with admission eosinopenia other than prior systemic corticosteroid use.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 35 Years and over
- Who can join: All genders
What the study is looking for
- ✓Admitted to hospital with primary clinical diagnosis of exacerbation of COPD\*
- ✓Smoking history of at least 10 pack years
- ✓Airflow obstruction: FEV1/FVC ratio \< 0.7 confirmed on historic or inpatient spirometry
- ✓Capacity to give agreement to take part to participate
Who cannot take part
- ✗Active cancer
- ✗Maintenance oral prednisolone or other systemic steroids, anti-interleukin 5 therapy or other medication known to...
- ✗Patients with poor venous access
- ✗Investigator confirmed history of asthma
- ✗Non-COPD related health problems which in the view of the primary investigator may compromise the conduct and...
See the full criteria
Where Is This Study? (1 UK site)
Northumbria Healthcare NHS Foundation Trust
North Shields, United Kingdom
How to Get in Touch
Stephen Bourke, MBChB, PhD
Sponsor contactCONTACT
Peter Ireland, MBBS
Sponsor contactCONTACT
