Status:

RECRUITING

Eosinopenia in Severe COPD Exacerbation

Lead Sponsor:

Northumbria Healthcare NHS Foundation Trust

Collaborating Sponsors:

Newcastle University

Chiesi UK

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

35+ years

Brief 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)...

Detailed Description

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 recru...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 22 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06188065

Start Date

January 22 2024

End Date

July 1 2026

Last Update

March 28 2025

Active Locations (1)

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Northumbria Healthcare NHS Foundation Trust

North Shields, United Kingdom