The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

Asthma Clinical Trial

Official title:

The Clinical Profile of UK Asthma Patients With Raised Blood Eosinophils

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02140541
• Other study ID #: R05812
• Status: Active, not recruiting
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 14, 2014
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2014
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130248
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	Research in Real Life Ltd	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Teva Pharmaceuticals USA

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Deykin A, Lazarus SC, Fahy JV, Wechsler ME, Boushey HA, Chinchilli VM, Craig TJ, Dimango E, Kraft M, Leone F, Lemanske RF, Martin RJ, Pesola GR, Peters SP, Sorkness CA, Szefler SJ, Israel E; Asthma Clinical Research Network, National Heart, Lung, and Blood Institute/NIH. Sputum eosinophil counts predict asthma control after discontinuation of inhaled corticosteroids. J Allergy Clin Immunol. 2005 Apr;115(4):720-7. — View Citation

Green RH, Brightling CE, McKenna S, Hargadon B, Parker D, Bradding P, Wardlaw AJ, Pavord ID. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet. 2002 Nov 30;360(9347):1715-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbations	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	1 year	No
Primary	Asthma control	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	1 year	No

External Links

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