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Eosinopenia in Severe COPD Exacerbation

ConditionChronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35+
SponsorNorthumbria Healthcare NHS Foundation Trust

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants will be aged 35 years and over. They will have been admitted to hospital with an exacerbation of COPD +/- eosinopenia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Participants with severe exacerbation of COPD and eosinophils < 0.05 x 10^9/L1 intervention
Group B: Participants with severe exacerbation of COPD and eosinophils >= 0.05 x 10^9/L1 intervention

Trial outcomes

Primary outcomes

1

Indices independently associated with eosinopenia on admission in patients with a severe exacerbation of COPD.

Candidate indices will be identified by both univariate analysis (inclusion of indices related to eosinopenia at the 0.1 threshold) and domain knowledge (inclusion of indices thought likely to be related to eosinopenia even if no association on univariate analysis). Summary indices will also be created to reduce the number of variables (e.g. evidence of bacterial infection will include positive blood culture, sputum culture or antigens). Once candidate indices have been identifed, collinearity will be addressed and then independent associates of eosinopenia will be identified by logistic regression using backwards stepwise elimination.

Time frame
On admission date
2

The time taken for BEC to recover to stable state following a severe exacerbation of COPD.

Time frame
1, 2, 3, 4 and 6 weeks from admission date

Secondary outcomes

1

Level of agreement between the index admission eosinophil phenotype and prior admissions for exacerbations of COPD since May 2019.

Time frame
On admission date
2

Change from baseline cytokine levels at day 28m stratified by intercurrent exacerbation or other acute illness status, including sub-group analysis (eosinopenic cohort vs non-eosinopenic cohort)

Time frame
On admission date and 4 weeks from admission date
3

The proportion of patients whose BEC reaches 100 cell/uL or higher at each visit.

Time frame
1, 2, 3, 4 and 6 weeks from admission date
4

The time taken to reach peak BEC after a severe exacerbation of COPD.

Time frame
1, 2, 3, 4 and 6 weeks from admission date

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northumbria Healthcare NHS Foundation Trust

Lead sponsor

Newcastle University

Collaborator

Chiesi UK

Collaborator

GlaxoSmithKline

Collaborator

Source ClinicalTrials.gov
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