Identifying factors related to low eosinophil counts in severe COPD exacerbations
Associates of, and Time to Recovery From, Eosinopenia in Severe COPD Exacerbation
This study is trying to find out what factors are linked to low eosinophil counts in people with severe COPD flare-ups to help improve treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Northumbria Healthcare NHS Foundation Trust Academic / other |
| Locations | 1 site (North Shields) |
| Trial ID | NCT06188065 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify factors associated with low eosinophil counts in patients experiencing severe exacerbations of chronic obstructive pulmonary disease (COPD). It will assess demographic, physiological, and clinical characteristics that correlate with eosinopenia upon hospital admission. Additionally, the study will evaluate the time it takes for blood eosinophil counts to return to baseline levels after recovery from a severe exacerbation. The findings could help refine treatment decisions regarding inhaled corticosteroids in COPD management.
Who should consider this trial
Good fit: Ideal candidates for this study are patients admitted to the hospital with a primary diagnosis of severe COPD exacerbation and a significant smoking history.
Not a fit: Patients with conditions that cause high eosinophil counts or those currently on medications that influence eosinophil levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for COPD patients by better identifying those who would benefit from inhaled corticosteroids.
How similar studies have performed: While the use of eosinophil counts as a biomarker in COPD management is established, this specific approach to studying eosinopenia during exacerbations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 informed consent to participate Exclusion Criteria: * Parasitic infection, systemic fungal infection (excluding infection limited to nails or skin), eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome or other conditions associated with a high eosinophil count# * Active malignancy * Maintenance oral prednisolone or other systemic steroids, anti-interleukin 5 therapy or other medication known to influence eosinophils * 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 completion of the study ADDITIONAL CRITERIA FOR THE TIME TO RECOVERY FROM EOSINOPENIA ANALYSIS ONLY Inclusion criteria: * Eosinopenia on admission * Uneventful recovery\* * Eosinopenia on admission who do not receive a further course of systemic corticosteroids or require emergency hospital admission for an acute illness in the six weeks following admission to hospital with a severe exacerbation of COPD.
Where this trial is running
North Shields
- Northumbria Healthcare NHS Foundation Trust — North Shields, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Peter Ireland, MBBS — Northumbria Healthcare NHS Foundation Trust
- Study coordinator: Stephen Bourke, MBChB, PhD
- Email: stephen.bourke@nhct.nhs.uk
- Phone: 0191 293 4351
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.