The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

• Conditions: Asthma

• Registration Number: NCT02140541
• Lead Sponsor: Research in Real-Life Ltd

Brief Summary

To explore the relationship between blood eosinophil counts, asthma exacerbations and patient asthma control using a large primary care based research database

Detailed Description

Sputum eosinophil levels have been shown to predict asthma exacerbation and inhaled corticosteroid (ICS) responsivenesss. Managing asthma based on sputum eosinophils leads to fewer exacerbations than management adhering to Global Initiative for Asthma (GINA) guidelines. However the use of sputum to measure eosinophil levels is expensive and impractical within a clinical setting. This study explores the use of blood-eosinophil levels as a clinical predictor for exacerbations and asthma control within a UK primary care dataset.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-14
• Study First Posted: 2014-05-16
• Last Update Posted: 2014-05-16
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130248

Inclusion Criteria

• Patient aged 12-80 at date of last eosinophil count
• Asthma diagnosis at any time
• Blood Eosinophil reading in patient record (numeric count expressed in µl) at least one year prior to last data extraction
• Two years of continuous data

Exclusion Criteria

• Any other chronic respiratory diseases
• Eosinophil counts >5000/µl (outliers)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exacerbations	1 year	Defined as: * American Thoracic Society / European Respiratory Society (ATS/ERS) task force definition: Asthma related hospital admissions OR accident and emergency (A\&E) room attendance OR Use of acute oral steroids; * Clinical definition: ATS/ERS definition including any GP consultations for lower respiratory related tract infections (LRTIs) treated with antibiotics
Asthma control	1 year	Defined as: * Risk domain asthma control: No Asthma-related hospital attendance, A\&E attendance, out-patient department attendance, no prescriptions for acute oral steroids and no GP consultations for LRTIs treated with antibiotics; * Overall asthma control: Risk domain asthma control definition, including average daily dose of ≤200mcg salbutamol

Trial Locations

Locations (1)

Research in Real Life Ltd; 🇬🇧 Cambridge, United Kingdom