Eosinopenia in Severe COPD Exacerbation (NCT06188065) | Clinical Trial Compass
RecruitingNot Applicable
Eosinopenia in Severe COPD Exacerbation
United Kingdom200 participantsStarted 2024-01-22
Plain-language summary
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
Who can participate
Age range
35 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:
* 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.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Indices independently associated with eosinopenia on admission in patients with a severe exacerbation of COPD.
Timeframe: On admission date
2
The time taken for BEC to recover to stable state following a severe exacerbation of COPD.
Timeframe: 1, 2, 3, 4 and 6 weeks from admission date
Trial details
NCT IDNCT06188065
SponsorNorthumbria Healthcare NHS Foundation Trust